Be visionary

Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.​

We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins.

Job Description

 Job Summary:

• To represent Product Assurance as part of a new US-based sonar development team to deliver development and acceptance testing to software and hardware development. A major part of this role will be managing and maintain a test boat which will be based close to the development team.

Primary Duties & Responsibilities:

• Maintain readiness of a Teledyne-owned boat which will be located close to the development team
• Provide Captain and or crew support for the test boat
• Manage the boat to a defined budget
• Ensure seatrials are safely deployed at all times
• Ensure planned maintenance routines are carried out on the hull and fitted equipment
• Provide installation support & guidance for the fitting of Raymarine test products
• Liaise with local marinas and boat maintainers to achieve the above
• Requirements Capture – Input to requirements capture for assigned projects from a mariners and/or test perspective
• Product Qualification – Develop via analysis; create and conduct complex test plans that can be used by other team members to assess product performance & reliability
• Engineering QA – provide resource to control product build status/issue within product development.
• Benchmarking – conduct comparison/benchmark tests as a part of research & development for new and potential products
• Quality policy – ensure all activities meet the spirit of the policy
• Personal training – identify additional training appropriate for current or future work
• Carry out and contribute to risk assessments of issues from a mariner or user’s perspective

Job Qualifications:
 

Formal Education/Qualifications required:

• Formal qualification in a technical discipline preferred (electrical, electronic or software test) or
• On the job training to an equivalent standard or

The following would be essential:

• 3 Years + experience in a relevant technical role
• Boating experience as a regular crew or skipper
• Ability to install electronic/electrical equipment on a Sports Fishing Boat

The following would be desirable but not essential:

• Boat skipper qualifications
• Graduate in a relevant engineering discipline
• Experience in the US Sports Fishing market
• Relevant product testing experience
• Ability to use PC applications

Applicants must be either a U.S. citizen, U.S. national, legal permanent resident, asylee, refugee or must be eligible to apply for and obtain the appropriate export control license from the U.S. Departments of State or Commerce.

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws. ​

Quality Control Systems Lead

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Quality Control Systems Lead is Responsible for managing the logistical functions associated with the daily operation of the Quality Control laboratories. Supervises the colleagues responsible for sampling raw materials. Maintains documents and records, coordinates the receipt and storage of all raw materials, and assists in communicating the needs of the business to the Quality Control Laboratories. 

Key responsibilities:

• Manages the raw material sampling program for the Hard Capsule, Liquid Filled Capsule, and Ingredients businesses on-site through the supervision of those responsible with performing sampling. (documentation, delivery, shipping, storage, etc.)
• Schedules material movements with warehouse and logistics team and executes raw material usage decisions in the SAP system.
• Coordinates raw material sampling and testing priorities with multiple cross-functional teams for each on-site business.
• Supervises the generation of testing documentation (working papers, test forms, and sample labels)
• Communicates pre-ship sample approvals with suppliers and global teams as needed.
• Responsible for creating and maintaining QIR (Quality Information Records) and QM (Quality Management) information for raw materials in SAP ERP system.
• Supervises the scanning/filing/storage/archival of physical and electronic documentation. (analysis documents, calibration certificates)
• Manages the raw material retain sample program.
• Responsible for creating logbooks for lab testing and monitoring.
• Manages annual and quarterly samples received for Global Testing program and responsible for pulling Greenwood site samples quarterly.
• Supervises the submission and shipment of samples to contract labs for 3rd party testing.
• Manages internal and external requirements for ISO 17025 certification, including but not limited to: proficiency testing or inter/intra-lab comparison testing, internal auditing schedule, scope of certification, and recertification.
• Manages requests and submitting required documentation for IFANCA Halal certifications.
• Manages instrument and equipment calibrations and maintenance (scheduling, software, payment, etc.)
• Oversees management of laboratory supplies, chemicals and equipment (requisitions, direct buying)
• Responsible for departmental office supplies (inventory and ordering)
• Managing PPE Supplies for QC colleagues through external providers
• Responsible for communicating janitorial and facility maintenance needs to completion in the laboratory and office area.
• Must be able to work 40 hours a week, which may include weekends, holidays, etc.
• Must be able to work additional hours/days as business needs dictate
• Attendance in the plant site is considered an essential function
• Perform other duties as assigned. 

Key requirements:

• Associate degree or 5 years of administrative experience
• Experience in a quality oriented field

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Be visionary

Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.​

We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins.

Job Description

Essential Duties and Responsibilities:

• Track and facilitate production of deliverable units through all manufacturing areas. Ensure all deliverable products are completed on-time.

• Communicate problems quickly and to the appropriate contacts to ensure any issues slowing down or stopping production are resolved in a timely manner.  If issues cannot be resolved immediately, monitor progress and push to a resolution.

• Accurately update MRP (IFS) and Manufacturing Scheduling (WinMOPs) systems in a timely manner. Add production notes into WinMOPs daily so that any user can know the status of a deliverable line by COB each day.   

• Assist planning team with daily tasks.  Attend planning meetings as needed. 

• Comply with, and assist in the enforcement of all company safety policies.

• Maintain excellent communication and working relationship with all departments within the company.

• Creates new shop orders, tracks shop order material complete dates and releases shop orders for kitting.

• Aggressively tracks past due components and sub assembly shortages.

Education and Experience:

• A.S. Degree, Technical Certificate or APICS CPIM Certification a plus

• Minimum 3 years manufacturing experience preferred

Job Knowledge, Skills and Abilities:

• Advanced knowledge of manufacturing processes and “best practices”.

• Strong understanding of lean manufacturing, value-stream mapping & business process mapping a plus.

• Strong problem-solving skills a must

• Excellent internal and external customer facing skills

• Strong interpersonal communication skills - written & verbal.

• Professional appearance and behavior

• Excellent Organizational Skills, professional appearance and behavior

• Computer Literate- proficient in Microsoft Word, Excel, Outlook

• Ability to work in a fast-paced environment

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws. ​

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

 We are looking for professionals to grow with us and we have an exciting opportunity in our Finance group.  The Director US Tax Compliance - in close alignment with the Regional Head of Tax Americas - will manage the tax compliance processes for Lonza US entities (timely preparation and filing of all federal, state and local tax returns,  management of direct and indirect tax audits, tax support to Lonza businesses) and will work in the specific tax projects (research, studies, analysis, preparation of memos and presentations etc.) assigned by the Regional Head of Tax Americas

In this role, the Director US Tax Compliance will work with the Lonza US tax team/staff, by managing and coordinating the necessary activities, and will be directly involved (“hands-on”) in the preparation/review/analysis needed to successfully execute the tax compliance processes and the projects assigned.   

Key responsibilities:

• Coordinate the timely preparation and review of all federal, state, local tax returns for Lonza US Group US (including the US tax compliance of the non-US legal entities owned via Lonza US group) to ensure timely filing and compliance with applicable laws and regulations.  Manage the process of the return preparation by Lonza US tax team/staff.  Collect, analyze, and format financial information, work with Lonza US finance and accounting departments to gather information needed to complete all required tax forms/reports.  Manage tax compliance team/staff to assist in the collection of data and ensure that the information is properly reviewed to minimize errors.  Set deadlines with tax compliance team/staff for the completion of projects so that sufficient time is available to review information in detail prior to filing with tax authorities.
• Maintain tax software to be used to prepare all federal and state tax returns for Lonza US entities. 
• Maintain a tax depreciation software database to be used in order to correctly calculate the Federal and State Depreciation adjustments. 
• Preparation and review of estimated tax payments calculations to minimize excess tax payments and liaising with Lonza US Treasury department to pre-inform on the payments amount expected and to be executed.
• Investigate and implement tax optimization opportunities, including income exclusions and tax credits, to be pre-discussed and aligned with the Regional Head of Tax Americas. Ensure that best practices are employed to efficiently gather, use, document, and maintain the related supporting documentation in line with the applicable law and regulations. 
• Maintain professional and technical knowledge by attending educational workshops or classes; reviewing professional publications; establishing personal networks, and participating in professional societies.
• Manage the various tax notices and exams in such a manner that the position is knowledgeable enough of the laws/requirements so that the position can answer IRS and or state authority’s questions and concerns.
• Assist in the effective and efficient tax transition and consolidation of newly acquired Lonza’s entities under the Lonza US tax umbrella.
• Perform tax analysis/researches and prepare memorandums and presentations in relation to specific tax projects assigned by the Regional Head of Tax Americas
• Manage, under the lead of (and in close alignment with) the Regional Head of Tax Americas, federal, state & local tax audits from various US jurisdictions, negotiate with tax authorities and defend the positions taken by Lonza by maintaining complete and accurate files.  Make sure that sufficient information is gathered and maintained during the tax returns process to support amounts that might be questioned in the future under audit.
• Responsible for FATCA Compliance and maintaining W-8BENE forms and W-9 forms for all units within and out of the US.
• In close alignment with the Regional Head of Tax Americas, manage tax compliance team/staff and recommend and encourage training seminars to help them improve their tax knowledge and develop their careers.  Provide feedback to staff on projects completed.
• Align with Regional Head of Tax to ensure that Lonza’s global and US tax strategies and optimization of Lonza’s tax position are implemented and correctly reflected in the US tax returns and provisions.
• Frequently liaise with Regional Head of Tax Americas to discuss Lonza’s US tax position in general, and with respect to specific items identified as (materially) influencing Lonza’s US tax position. Timely inform Regional Head of Tax Americas about tax audits announced, and keep Regional Head of Tax Americas informed about progress and status of tax audits, discussing general approach, what information will be provided, negotiation positions, and the response to proposed adjustments.

Key requirements:

• Bachelors’ degree required, Masters’ degree in Taxation/Accounting preferred
• Significant years of experience in US Corporate Tax Compliance and Tax Accounting
• Experience leading multiple complex initiatives simultaneously
• Flexibility and willingness to perform other tasks assigned
• Ability to gather and organize large amounts of highly technical and specialized information from numerous sources
• Significant work experience interfacing with Tax function colleagues in US and Globally
• Highly proficient with time and process management

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Be visionary

Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.​

We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins.

Job Description

Job Summary:
 

Teledyne Technologies provides skilled trades services to major corporations in North America. We specialize in research and development, manufacturing operations, plant shut downs and building maintenance.

Our skilled trades include Tool and Die Makers, Instrumentation Techs, Multi-Craftsman , Machinists, Pipe-fitters, Carpenters, Electricians, Work Coordinators, EH&S, Welders, Preventative Maintenance Technicians , Planners, Glass Blowers and others.

Detailed Description:

Formal training in Instrumentation/Electrical with the ability to operate, test, repair, maintain and calibrate electro-mechanical equipment.

• strong knowledge in calibrating instruments of flow

• pressure and level transmitters

• thermocouples

• heaters 

• temperature controllers

• troubleshooting 480v and below

• repair 48ov and below

• workable knowledge of test meters

• install conduit 

• install wiring based on code requirements

• Analytical equipment troubleshooting/design and build

Requirements:
 

Two-year degree in a scientific field of study

• Preferred five years of experience in instrumentation, including experience in installing, calibrating, maintaining and repairing equipment 

• Demonstrated use and understanding of physical standards of mass, temperature flow and pressure.

• Working knowledge of computers.

• Required ability to be able to read and work from blueprints, schematic diagrams and specification manuals.

• Must be physically able to perform basic maintenance

• Must be able to work with various researchers in different locations

• Must have data base experience with record keeping and documentation accuracy

 Must have current Electrical Experience

• Preferred 3-5 years of troubleshooting experience working with 24V to 480v

• Must be a team player committed to working in a quality environment

• Must have electrical experience with Contacts, Mods, ABB Drives and relays

• Must have panel building experience

• Must have an understanding of regulatory and compliance regulations

We offer the following benefits
Health, Dental, Vision

Paid Vacation & Sick 

Life Insurance Benefits

 Paid Holidays, 401(k)

 Employee Stock Purchase Plan

Educational Tuition Reimbursement 

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws. ​

Job Description

General Summary:

The Quality Compliance Director provides strategic leadership for quality culture, inspection readiness, clinical to commercial transition, and escalation process for the cell and gene therapy business unit.  The role has specific focus on external and internal manufacturing/testing inspection readiness and ongoing compliance to changing regulatory expectations.  This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance. 

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

• Provides tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
• Leads inspection and compliance programs both internally and externally.  Works cross-functionally across many different functional areas and programs. 
• Provide leadership, strategic thinking, and mentorship to staff, focusing on employee development and leadership skills
• Leads and manages complex projects/teams within corporate objectives and project timelines
• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into inspection readiness and control strategies
• Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
• Be directly involved in and where appropriate, lead multiple process/product improvement projects which may include quality system process improvements, development of new methodologies and improving existing methodologies, data generation, report development and presentation
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products

  • Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams

  • Ability to evaluate quality matters and make decisions utilizing risk-based approach

  • Solid quality culture knowledge and understanding of how to influence and improve overall compliance

  • Strong presentation skills and ability to influence others

  • Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Be visionary

Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development, oceanographic research, deepwater oil and gas exploration and production, medical imaging and pharmaceutical research.​

We are looking for individuals who thrive on making an impact and want the excitement of being on a team that wins.

Job Description

Teledyne Technologies provides skilled trades services to major corporations in North America. We specialize in research and development, manufacturing operations, plant shut downs and building maintenance.

Our skilled trades include Tool and Die Makers, Instrumentation, Multi-Craft , Machinists, Pipe-fitters, Carpenters, Electricians, Work Coordinators, EH&S, Welders, Pipe Insulators, Carpenters, Preventative Maintenance Technicians , Planners, Glass Blowers and others.

Formal training in Instrumentation/Electrical

• strong knowledge in calibrating instruments of flow
• pressure and level transmitters
• thermocouples
• heaters 
• temperature controllers
• troubleshooting 480v and below
• repair 48ov and below
• workable knowledge of test meters
• install conduit 
• install wiring based on code requirements
• Analytical equipment troubleshooting/design and build

Two-year degree in a scientific field of study

• Preferred five years of experience in instrumentation, including experience in installing, calibrating, maintaining and repairing equipment 
• Demonstrated use and understanding of physical standards of mass, temperature flow and pressure.
• Working knowledge of computers.
• Required ability to be able to read and work from blueprints, schematic diagrams and specification manuals.
• Must be physically able to perform basic maintenance
• Must be able to work with various researchers in different locations
• Must have data base experience with record keeping and documentation accuracy

 Must have current Electrical Experience

• Preferred 3-5 years of troubleshooting experience working with 24V to 480v
• Must be a team player committed to working in a quality environment
• Must have electrical experience with Contacts, Mods, ABB Drives and relays
• Must have panel building experience
• Must have an understanding of regulatory and compliance regulations

 We offer the following benefits:
 Health, Dental, Vision

 Paid Vacation & Sick 

 Life Insurance Benefits

 Paid Holidays, 401(k)

 Employee Stock Purchase Plan

 Educational Tuition Reimbursement   

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders. Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws. ​

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Manager Quality, Operations (3rd Shift)

Live

What you will do

Let’s do this! Let’s change the world! In this role you will be managing the Plant Quality Assurance (PQA) team, responsible to lead all aspects of the assembly and packaging operations. A key aspect of this role is to ensure quality and compliance to GMP regulations for all assembly and packaging operations.

The Manager PQA will play a key role in the Quality Assurance team, focused on building a strong PQA team and establishing efficient Plant Quality processes. The PQA team leads all aspects of quality of manufacturing operations (assembly and packaging) and is responsible for batch disposition of the produced Finished Drug Product at the site. Your team will work closely with the manufacturing team to assure product is produced according to quality standards and in alignment with the regulatory filing. The team assures the Finished Drug Product is dispositioned in a timely manner to supply every patient every time.

You will support all activities for the set-up of the new assembly and packaging area, working closely with manufacturing to define production processes using a risk-based approach. You will build and own an impactful PQA team supporting manufacturing in a shift structure that may include second, third and/or weekend as a normal schedule.

• Own the realization of operational activities for PQA while providing technical expertise/guidance to the staff and ensuring Finished Drug Product is dispositioned in a timely manner; handle daily operations in relation to planning and management of the team and their tasks.
• Responsible for selection, training, evaluation, staff relations and development of staff. Interacts with management in optimizing organizational structure and responsibilities.
• Provide oversight of the QMS process implementation applied in manufacturing, including deviation management, CAPAs, work-orders and change controls.
• Interact with Manufacturing, Process Development and other partners for raised cases of deviations related to process, equipment or materials.
• Ensure that all operations follow applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Own and review related SOPs, methods, protocols and reports. Provide training and oversight for staff.
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for equipment implementation. Drive Lean Transformation and Operational Excellence initiatives.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 3 years of experience in the pharmaceutical, medical device or biotechnology industry

Or

Bachelor’s degree and 5 years of experience in the pharmaceutical, medical device or biotechnology industry

Or

Associate’s degree and 10 years of experience in the pharmaceutical, medical device or biotechnology industry

Or

High school diploma / GED and 12 years of experience in the pharmaceutical, medical device or biotechnology industry

And

Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

• Educational background in life sciences or equivalent
• Strong in managerial skills, coaching, mentoring and counseling
• Experience in a GMP controlled environment
• Familiarity with equipment commissioning and qualification activities
• Affinity with digital innovation and data sciences
• Excellent written and verbal communication, ability to work in a team matrix environment and build relationships with partners
• Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues
• Strong organizational skills, including ability to follow assignments through to completion

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

About Us:

How many companies can say they’ve been in business for over 177 years?!

Here at ZEISS, we certainly can! As one of the pioneers of science, ZEISS handles the everchanging environment of our fast-paced world, meeting it with cutting edge technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and with over 4,000 in the US and Canada alone! Make a difference, come join the team!

What’s the role?

As a Field Service Technician, you get to work with an astonishing team that plays a vital role in Carl Zeiss Industrial Quality Solutions, LLC. Show case your skills and experience by process enhancements focused on installation and servicing of custom equipment. You will interact with customers and cross functional service groups that support and launch ZEISS products into the field. Additionally, you will aid the R&D team with engineering work in relation to design, build, and new system testing. This position will also support the production of systems during various stages of assembly and setup.

Sound Interesting?

Here’s what you’ll do:

• Install, Repair, Troubleshoot, Service and Calibrate high tech machines at customer locations.

• Demonstrate customer service skills and knowledge with a high level of passion and dedication.

• Demonstrate your ability to learn new skills on high tech CMM’s (Coordinate Measuring Machines) utilizing mechanical and electronic aptitude.

• Perform necessary administrative paperwork in a complete and accurate manner.

• Be Solutions-oriented with the ability to work independently in a high pressure, fast-paced and innovative environment.

• Travel requirement is 90-100% within the service area, including international travel as needed.

• Other duties as required.

Do you qualify?

• Minimum, High School graduate, completed GED or equivalent.

• Or, Tech School, associate, or bachelor’s degree in a technical discipline such as, Electronics, Industrial Mechanics, and the like.

• Or, Training and experience from a Military Technical School.

• Prior experience working with hand tools and basic electrical test equipment.

• Microsoft operating system knowledge is required.

• Capable of unassisted physical lift of one article weighing up to 75 pounds.

• Able and willing to work minimum of 50 hours per work week. Regular + OT.

• Ability to work in an industrial production shop floor environment.

• Valid Driver License required.

• Excellent communication and customer service aptitude.​

Nice to haves:

• Previous experience installing and troubleshooting industrial electronics, machines, or computer systems.

• Previous CMM (Coordinate Measuring Machine) installation and troubleshooting experience is preferred however not required.

ZEISS is an EEO/AA/M/F/Disabled Veteran Employer

Your ZEISS Recruiting Team:

KEY DUTIES AND RESPONSIBILITIES 

• Keep inventory, purchasing, shipping and other records
• Put together data from purchase orders, invoices, requisitions, and accounting reports
• Determine stock supply and need for replenishment
• Look into damages, inventory adjustments, and shrink issues
• Find product to ensure correct product ID, conduct cycle counts regularly and assist in physical inventories
• Look at stock numbers, pallet IDs, authorized substitutes, and other listed information with catalogs, manuals, product lists, and similar references to verify accuracy of shipping order
• Review files to find unused items and recommend disposal of excess or damaged products

ADDITIONAL DUTIES AND RESPONSIBILITIES

• Operate warehouse material handling equipment to move product while following all regulatory and company safety standards, policies, and procedures.

MINIMUM REQUIREMENTS (KNOWLEDGE, SKILLS, ABILITIES)

• Ability to understand instructions in Country's official language or as defined by Lineage Logistics

• Excellent problem-solving skills and attention to detail
• Proficient computer skills, including Microsoft Office Suite
• Ability to work in temperatures as low as -20 Fahrenheit/-25 Celsius in cold storage sites or up to 100 Fahrenheit/37 Celsius in dry storage sites while wearing company provided personal protective equipment and freezer gear
• Must be able to lift a minimum of 40 lbs.; weight may be more dependent upon facility
• Ability to work a flexible work schedule and shift, including weekends if needed

Why Lineage?

This is an excellent position to begin your career path within Lineage! Success in this role enables greater responsibilities and promotions! A career at Lineage starts with learning about our business and how each team member plays a part each and every day to satisfy our customers’ requirements. Beyond that, you’ll help us grow and learn on our journey to be the very best employer in our industry. We’ll ask you for your opinion and ensure we do our part to keep you developing and engaged as we grow our business. Working at Lineage is energizing and enjoyable. We value respect and care about our team members.

Lineage is an Equal Employment Opportunity Employer and is committed to compliance with all federal, state, and local laws that prohibit workplace discrimination and unlawful harassment and retaliation.  Lineage will not discriminate against any applicant on the basis of race, color, age, national origin, religion, physical or mental disability or any other protected status under federal, state and local law.

Benefits

Lineage provides safe, stable, reliable work environments, medical, dental, and basic life and disability insurance benefits, 401k retirement plan, paid time off, annual bonus eligibility, and a minimum of 7 holidays throughout the calendar year.

Job Description

General/Position Summary

The Senior Director, Quality be responsible for the oversight of Product Quality/ External Manufacturing of Cell & Gene Programs.  The role will be responsible for supporting the commercial transition of the Cell & Gene quality  strategy to meet business, regulatory and operational requirements.

The is a critical role within Quality department responsible for managing CDMO partnerships to ensure that the company effectively and efficiently delivers medicines to patients. This role is also directly responsible for co-leading joint project teams with CDMO’s.

This position will be based in Vertex’s corporate headquarters in Boston, MA. This role will partner closely with operational stakeholders to ensure seamless supply of all clinical and commercial products and to lead/support the development and execution of quality projects.   The senior director of quality will also participate in Cell & Genetic therapies projects and governance committees covering external manufacturing. 

**This is a hybrid role working 3 days on-site and up to two days remotely.**

Key Duties & Responsibilities

• Establishment of quality oversight for external CMO operations.
• Prioritize, develop and implement systems, processes and tools to ensure that the systems, processes and resourcing are optimal for transition from development through product life cycle and set up to scale efficiently and effectively.
• Ensure appropriate metrics and tracking are in place for operational monitoring and as early key indicators for operational issues.
• Represent Quality in Cell & Gene Programs and serve as a trusted advisor and partner to establish the CMC quality strategy and roadmap for innovative therapeutic programs.
• Support GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.
• Provides quality leadership and partner with operational stakeholders to ensure efficient operations and mitigation of risks. Support/lead risk management activities, including identification of gaps, implementation of mitigation plans and associated execution.
• Provide significant CDMO-focused regulatory filing input (IND, BLA, etc) and drive operations-focused pre-approval inspection and commercial readiness activities at the CDMOs.  Adjudicate compliance discussions, and negotiate any required corrective actions.
• Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.
• Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.
• Lead and mentor other team members, support development of organizational capabilities and talent building.

Required Education Level

• Bachelor’s and Master's degree in a Scientific/Technical/Business discipline.

Required Experience

• 15+ years of experience and 7+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

• Experienced in quality assurance operations role  for a allogeneic/autologous cell manufacturing process.
• In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
• Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
• Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
• Current knowledge of industry trends and best practices in Cell/Gene therapies.
• Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Ability to apply risk management principles to decision making and operational priorities.
• Critical Thinking and Problem Solving skills

Other Requirements
 

15% travel

Hybrid role in Boston, MA

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Cardinal Health Overview:

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities.

We are a crucial link between the clinical and operational sides of care, working with more than 4,500 sourcing and manufacturing partners to deliver end-to-end solutions and data-driven insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.

With 50 years of experience, approximately 44,000 employees and operations in more than 30 countries, Cardinal Health seizes the opportunity to address healthcare’s most complicated challenges — now, and in the future.

Department Overview:

Information Security and Risk Management (ISRM) at Cardinal Health enables Cardinal Health to securely deliver healthcare products and solutions that improve the lives of people every day by ensuring security and controls is embedded into Cardinal Health’s people, process and technology.

We currently have a career opening for a Sr. Engineer, Information Security and Risk, who will play an IT Privacy Compliance Program Run Lead role focused on driving IT Privacy Controls & Compliance for the organization.

Job Overview:

This role is a leader position within the team and requires having an in-depth understanding of local, national and international privacy and security regulations such as HIPAA (Health Insurance Portability and Accountability Act), GDPR (General Data Protection Regulation) and the CCPA (California Consumer Privacy Act) as well as relevant control frameworks to drive compliance to those regulatory requirements such as NIST, ISO, etc., while working with members of the Information Security and Risk Management team as well as privacy leaders in Legal, Ethics & Compliance and our various businesses throughout the Cardinal Health enterprise.  Senior Engineer will be responsible for managing operational activities (i.e., “Run”) of the IT Privacy Compliance Program, including confirming all assessments are completed, issue management and maintaining operational metrics. 

Daily Responsibilities:

• Leader over the “Run” activities of the IT Privacy Compliance Program as a Second Line of Defense (LOD) function.  Some of the key responsibilities include:
  • Create and manage calendar of IT Privacy Risk Assessments, while collaborating with appropriate risk functions to reduce redundancy of efforts, enhance reliance on Second LOD, and provide coverage across in-scope assets.
  • Lead management of all issues resulting from assessments to confirm appropriate stakeholder visibility and remediation recommendation, appropriate issue lead assignments, appropriate issue validation prior to closure, etc.
• Collaborate with IT Privacy Compliance Program Build Lead on driving overall success of the program.
• Build and implement metrics to report on effectiveness of the IT Privacy Compliance Program
• Partner with Legal counsel and Ethics & Compliance leaders to address regulatory or compliance requirements, issues, concerns or questions.
• Partner with IT and IT Security in the development of policies, procedures and practices in support of privacy and data protection compliance.
• Collaborate with IT and business leaders and team to provide guidance on doing privacy by design and remediating issues identified to enhance compliance to the regulatory requirements.
• Identify opportunities to automate various privacy and data protection compliance activities to reduce the overall cost of compliance.
• Mentor members of the team on how to effectively perform compliance assessments, complying to IT privacy regulation requirements, consultation on issue remediation recommendations and alternative solutions, etc.
• Effectively manage and implement change throughout the organization.

Qualifications:

• Bachelor’s Degree in related field or equivalent work experience
• 10+ years’ experience in related field
• Prior experience with key IT Privacy regulation compliance including HIPAA and GDPR compliance.
• Prior experience with control frameworks (e.g., NIST, HITRUST, COBIT, COSO, and ISO) to drive IT Privacy regulatory compliance.
• Prior experience working with Internal or External Audit functions are a plus.
• Experience with IT risk and controls identification and assessments including IT control design and effectiveness testing.
• Experience with GRC (Governance, Risk and Compliance)
• Experience in analyzing data and creating reports/dashboards/views to provide visibility into risk and control landscape.
• Ideal candidate will have excellent communication skills (both verbal and written) with leaders at all levels within the organization, an ability to work in a matrixed environment to drive results, and the ability to clearly define and execute repeatable processes.
• Ideal candidate will have an effective time management, active listening, meeting facilitation, and influencing skills.
• Ability to effectively navigate a variety of challenging environments, prioritize work and determine when to escalate to upper management.
• Security or risk certifications such as CISA (Certified Information Systems Auditor), CISSP (Certified Information Systems Security Professional) and/or CIPP (Certified Information Privacy Professional) certifications are a plus.

Anticipated salary range: $119,800 - $171,100

Bonus eligible: Yes

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 3/11/2024 *if interested in opportunity, please submit application as soon as possible.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here

What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Job Summary

The Senior Specialist, Quality Assurance is responsible for providing regulatory submissions in electronic format – drug establishment and drug listing requirements for Structured Product Labeling (SPL) format for repackaging and private label Rx and OTC. This individual will contribute to the oversight of Cardinal Health Pharmaceutical Private Label and of approved suppliers, manufacturers and repackagers.

Responsibilities

• Contribute to designing effective procedures, work instructions and/or processes to ensure compliance as well as efficiency.
• Processing Electronic Registrations and Drug Listings for repackaging.
• Clear understanding of guidelines for Structured Product Labeling (SPL) for both Rx and OTC.
• Data development and maintenance for repackage items in portfolio.
• SOP development and maintenance.
• Determine compliance of processes and regulations.
• Identify potential gaps to mitigate risk
• Implement improvements to internal processes.
• Works on complex projects.
• Acts as a mentor to those with less experience.
• Other activities as requested.

Qualifications

• BA, BS or equivalent experience in related field preferred
• 3-5 years of experience preferred.
• Comprehensive experience with Structured Product Labeling (SPL) preferred.
• Knowledge of cGMPs, 21 CFR 11, 210, 211, 820 and Structured Product Labeling (SPL) requirements preferred.
• Comprehensive knowledge of repacking operations preferred.
• Demonstrate critical thinking skills.
• Proficient with Microsoft Excel.
• Comprehensive knowledge and familiarity with products, processes, equipment, and facilities of pharmaceutical manufacturing and packaging.
• Comprehensive experience with drug/cosmetic listings preferred.
• Ability to work independently.
• Able to multitask and to reprioritize as required.
• Excellent interpersonal and critical thinking skills.
• Ability to travel 5% for in person meetings and/or regulatory inspections.

Location

• Fully remote
• Ability to travel up to 5% required for in person meetings and/or regulatory inspections.

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range: $66,500-$95,000

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 03/29/2024 *if interested in opportunity, please submit application as soon as possible.

#LI-Remote

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

DIRECTOR, CLINICAL QUALITY THERAPEUTIC AREA LEAD

Live

What you will do

Job Description

Let’s do this! Let’s change the world! In this vital role you will report to the Associate Vice President, Clinical & Research Quality (CRQ) and be responsible for a team of 5-10 colleagues. The Director, Clinical Quality Therapeutic Area Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development program.

Director, Clinical Quality Therapeutic Area Lead will manage end to end Quality Oversight within one of three Therapeutic Areas (TAs): Oncology/Biosimilars, Immunology & Rare Diseases, and General Medicine. The TA Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will be a vital role who develops deep knowledge of the TA’s clinical trials and provides oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities

• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
• Provide oversight for the development and implementation of Quality Plans
• Establish Regional expertise to ensure quality and compliance to local regulations
• Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
• Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits)
• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

Basic Qualifications:

Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience

Or

Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience

Or

Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• 5 years of managerial experience directly leading people in a multi-tiered organization and an ability to build a high performing team.
• 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. (including oversight of CAPAs, deviations, etc.)
• Thorough understanding and deep knowledge of Clinical Development activities / Clinical Trials and Global Regulations.
• Knowledge of the Regulatory Submission and Inspection Management procedures.
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
• Excellent verbal and written communication skills, including strong business writing abilities and active listening.
• Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
• Strong analytical, critical-thinking, and decision-making abilities.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will acquire the valuable hands-on skills and foundational experience to become the professional you are meant to be in your chosen field.

Undergrad Intern - Global Supply Quality - Contract Manufacturing Quality

Live

This could be your everyday

Let’s do this. Let’s change the world.

Operations is one of three foundational functions at Amgen with a mission to manufacture and deliver safe and effective medicine to patients around the world. Utilizing external contracted manufacturing services is a key strategy to ensure the delivery of Amgen products to our patients. Global Supply Quality’s (GSQ) objective is to ensure the quality of the materials and products we receive from our external suppliers and contract manufacturers. The North America arm of Global Supply Quality is seeking a highly motivated, hardworking undergraduate to fulfill a 2024 summer internship role under supervision of the Director of the organization. This internship will be approximately 12 weeks and includes both project-based and experiential learning. This position is to be fulfilled in a remote work setting, with the possibility of travel to internship events at one of our locations. The intern will be an integral member of the North America Global Supply Quality organization and will be focused on applying innovation and data driven strategies to simplify processes. The areas to be supported include: Portfolio Management, Business Operations, and Continuous Improvement. As a member of Amgen's GSQ Organization, your work will be highly collaborative across multiple functions and levels within Amgen, including, for example: Quality, External Supply, Supply Chain, Engineering, Diversity, Inclusion & Belonging, and others. You will be uniquely responsible for one or more key projects that will advance GSQ’s mission, including the following:

• Developing a project charter to map out objectives and identify key stakeholders, timelines, and deliverables
• Leveraging your analytical, leadership, communication, and interpersonal skills to work in teams, identify problems, conduct research, develop recommendations through qualitative and quantitative analysis, and deliver final projects
• Presenting your deliverables/findings through various forums including an intern-wide poster session and a final readout to executive management
• You will also be engaged in learning activities, networking with colleagues across the company, and enjoying full access to Amgen’s Employee Resource Groups

This job description serves as a general outline for the responsibilities of an undergraduate intern in GSQ. The specific tasks and requirements may vary depending on the organization and its projects.

Win

Here’s what it takes to Win

We are all different, yet we all use our unique contributions to serve patients. The individual we seek should be self-motivated and display the following qualifications:

Basic Qualifications

Amgen requires that all individuals applying for an undergrad internship or a co-op assignment at Amgen must meet the following criteria:

• 18 years or older
• Currently enrolled in a full-time Bachelor’s Degree program from an accredited college or university with a 3.0 minimum GPA or equivalent
• Completion of one year of study from an accredited college or university prior to the internship commencing
• Enrolled in a full-time Bachelor’s degree program following the potential internship or co-op assignment with an accredited college or university
• Must not be employed at the time the internship starts
• Student must be located in the United States for the duration of the internship OR co-op

Preferred Qualifications

• Majoring in Engineering or a Biotech related STEM discipline
• Interest in Project Management and Finance
• Strong communication, interpersonal, organizational, project management, and problem-solving skills
•  Strong analytical and quantitative skills
• Demonstrated personal initiative, self-motivation, flexibility and adaptability

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth in addition to their well-being:

The base pay range for this opportunity in the U.S. is $24.70 - $28.30 per hour.

• Build a network of colleagues that will endure and grow throughout your time with us and beyond.
• Bring your authentic self to the table and become the professional you’re inspired to be through accepting a culture that values the diversity of thought and experience and will flex to your strengths and possibilities.
• Participate in executive and social networking events, as well as community volunteer projects.

Apply now

for an internship that defies imagination

If you feel like you're part of something bigger, it's because you are. Join us.

careers.amgen.com Please search for Keyword R-179444

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Salary Range