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.

SENIOR MANAGER, IN-VITRO DIAGNOSTICS/ PRECISION MEDICINE QUALITY

Live

What you will do

Let’s do this! Let’s change the world! In this vital role you will report to the Senior Director, In-Vitro Diagnostics (IVD) and Precision Medicine Quality. The Senior Manager, In-Vitro Diagnostics/ Precision Medicine Quality supports the use of In-Vitro Diagnostics (IVD), including Companion Diagnostics (CdX), and Precision Medicine applications to clinical development. This role is responsible for supporting the implementation of an end to end, proactive and risk-based Quality Assurance strategy for IVD, and Precision Medicine, including third-party collaborations.

The In-Vitro Diagnostics/ Precision Medicine Quality strategy is focused on all aspects of research and development at Amgen, spanning from discovery through the entire lifecycle of clinical development. This strategy will ensure that all Amgen’s business procedures meet internal and external quality standards, and that they are managed for optimum efficiency and effectiveness. The In-Vitro Diagnostics/ Precision Medicine Quality strategy also ensures that the business develops and manages fit for purpose standards (SOPs and quality agreements). In addition, the strategy will ensure that Amgen’s QMS is continuously improved upon using quality by design, risk assessments, and outputs from the Quality Management System, including analytics showing quality trends and potential continuous improvement opportunities.

Responsibilities

• Develop collaborative partnerships with Research and Development (R&D) to help establish the state of quality and potential areas of quality risk exposure. Contributes to the use of innovative methods for improving the quality oversight for Amgen’s IVD and Precision Medicine programs.

• Collaborate with colleagues in a cross-matrixed environment and ensure that Amgen’s R&D efforts, including partnerships and third parties, are aligned to industry best practices and all regulations.

• Support the implementation of IVD quality management strategies to ensure compliance to an evolving and complex IVD regulatory landscape, particularly in the European Union.

• Leverages metrics (KQI, KPI leading and lagging) related to IVD and Precision Medicine for Quality Management System performance and improvement.

• Collaborate with clinical trial teams to ensure that all respective critical to quality components are incorporated into clinical trial design, execution, and support of regulatory filings.

• Maintain up-to-date knowledge of IVD regulations and applicable guidance; monitor development of regulations and communicate impact to the business.

• Provides risk-based quality assurance and oversight for IVD/ Precision Medicine activities (e.g., auditing, deviation management and inspection management).

• Ensures that all applicable integrated procedures (e.g., acquired assets) are fit for purpose and aligned to Amgen’s standards.

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 2 years of quality management experience OR

Master’s degree and 6 years of quality management experience OR

Bachelor’s degree and 8 years of quality management experience OR

Associate’s degree and 10 years of quality management experience OR

High school diploma / GED and 12 years of quality management experience

Preferred Qualifications:

• At least 3 years of experience in the pharmaceutical/biotech or medical device industry working within quality a quality management system role, or other relevant experience in clinical research that includes quality oversight (e.g., deviation management/CAPA, audit conduct, or inspection support.

• An understanding of medical device development and applicable Global Regulations.

• An understanding of Precision Medicine and applicable Global Regulations.

• An understanding of Quality Management Systems (QMS), including electronic QMS such as Veeva or TrackWise (Sparta Systems).

• Experience preferred working within research and development of In-vitro Diagnostics.

• Implementation of technology to improve knowledge management across a diverse R&D environment.

• Experience with compliance to GxP requirements including the oversight of third-party vendors, suppliers, and partners.

• Ability to incorporate business and customer feedback into clear, efficient processes using a straightforward language and format.

• Strong analytical, critical-thinking, and decision-making abilities, including development and implementation of Analytics methods and technology in order to enable signal detection and quality improvement.

• Innovative thinking, including the application of quality by design principles

• Collaborative worker with an ability to support a high performing team.

• Excellent verbal and written communication skills, including strong business writing abilities and active listening.

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

Flowserve is a world-leading manufacturer and aftermarket service provider of comprehensive flow control systems. Driven by our Purpose, we are committed to building a more sustainable future to make the world better for everyone. With more than 16,000 employees in more than 50 countries, we combine our global reach with local presence. We support more than 10,000 customers worldwide, creating products to meet the needs of our customers who are supplying energy, fresh water, pharmaceuticals and other essentials to consumers, businesses and governments globally.

Join a company where the people challenge themselves to approach each situation with ingenuity and creativity to help provide our customers with the most innovative flow control products and services. You will be part of a team known for its industry-leading talent, unparalleled portfolio, and unmatched commitment to customer success. Flowserve’s culture promotes recognition and rewards creativity, hard work, and commitment. We invite you to put your talents and career in motion at Flowserve

Supplier Quality Engineer Specialist

Role Summary:

Responsible for driving Supplier Quality Improvements, working directly with suppliers on Supplier/Process Approvals (Audit), Part Qualification (Flowserve Part Approval Process [FPAP]) and Non-Conforming Report (NCR) Resolution to include Containment, Root Cause, Corrective and Preventative Action. Identify trends within accountable Supplier population and where deemed appropriate, engage central Supplier Development Team for further detailed supplier improvement support activity.

Responsibilities:

• Lead the deployment of problem solving and improvement plans with suppliers. 
• Partner with manufacturing sites and Global Quality to analyze data on supplier performance and identify areas of focus. 
• Support in customer complaints / escapes problem solving (RCA/CA).
• Perform verification audits to suppliers to ensure Corrective Action implementation and sustainability (Control Plan).
• Lead process and product audits to suppliers to verify compliance on Flowserve expectations. 
• Facilitate and/or lead PPAP programs as dictated by procurement strategy (preventive) or quality performance (corrective).
• Support the update and maintenance of different Flowserve platforms: AVL, Assessment documentation, SCAR and CAPA registers. 
• Work with a proactive approach to assure Supplier KPIs compliance and reporting (Non-conformances, Rework, Scrap, First Pass Yield, Escapes, Warranties, Corrective Actions).
• Foster Continuous Improvement culture by leading projects associated with suppliers Cost of Poor Quality. 
• Assure safety rules are followed as a moral authority in the suppliers’ facilities. 
• Support maintaining all Quality certifications for the business (ISO 9001:2015, others site specific) as well as external audits (customer or third party).
• Act with an enterprise and collaboration mindset

Requirements:

• Bachelor’s degree in engineering field (manufacturing, industrial, or mechanical)
• 8 years of experience in Supplier Quality Assurance, no leadership experience required.  
• Previous experience in metal-mechanic industries and similar business.
• ISO 9001:2015 Lead Auditor
• Overall knowledge of API, ASME (Section II, V, VIII, IX) standards.
• Skilled in Team Oriented Problem Solving & Corrective Action management (8D, A3).
• Prior experience leading APQP, PPAP, FAI, GD&T, Control Plan (Core Tools)
• Lean Six Sigma Black Belt or Certified Quality Engineer or equivalent.
• Skilled in data analysis and quality KPI performance management.
• Experience in Quality Software Systems 
• Proficient in Microsoft Office
• English bilingual, business conversation.
• Must be able to travel both domestic and international 50% of time. 
• Outgoing proactive mindset and strong collaborative and communication skills  

Flowserve offers competitive pay, annual bonuses, medical benefits on day 1, generous paid vacation time, paid holidays, 401(k) and many other excellent benefits!

The Oshkosh Corporation Vocational segment leverages the power of our people, brands, and strength in technology to improve the safety, cleanliness, and productivity of our communities.  The Vocational segment includes market leading brands McNeilus, Oshkosh S-Series, IMT, Pierce, MAXIMETAL, Oshkosh Airport Products, and Frontline Communications.  Our purpose-built products serve our communities with carefully designed and engineered refuse trucks, front-discharge mixer trucks, fire apparatus, Airport Rescue and Fire Fighting trucks, service vehicles, and command trucks.   Our products are designed to perform under the toughest conditions.

The Associate Supplier Quality Engineer will support the supply chain organization with the planning and execution of processes designed to improve overall supplier performance (quality, delivery, and cost). This role will interface with individual buyers and category managers, departments, and/or segments.

YOUR IMPACT

• Perform component inspections to engineering specifications to validate nonconformance.
• Support Supplier Production Part Approval Process, validate submissions to Engineering requirements.
• Support and maintain standard work procedures as it relates to supply base performance.
• Validate supplier capabilities, capacity, and quality systems using self-audits and on-site audits.
• Address short term performance issues through 8D/SCAR and rapid continuous improvement. 
• Assist with the identification of standard work and process needs by collaborating with stakeholders.
• Apply tools from lean principal methodology to drive continuous improvement efforts related to supply chain performance.
• Coach, mentor, and train suppliers in continuous improvement.
• Lead/participate in launch readiness programs.
• Monitor supplier quality and delivery performance.

MINIMUM QUALIFICATIONS

• Bachelor’s degree in Engineering or Engineering Technology
• Travel up to 25% (local and/or domestic)

STANDOUT QUALIFICATIONS

• Software experience with Jaggaer, Reliance or JDE
• Ability to interpret weld, electrical, and print drawings
• Supply Chain experience within the manufacturing industry
• Strong organizational skills with exceptional follow through and attention to detail
• Strong time-management and prioritization skills, able to multi-task and prioritize competing requirements and meet deadlines
• Ability to work in a fast-paced environment where requirements are constantly changing

Oshkosh is committed to working with and offering reasonable accommodations to job applicants with disabilities. If you need assistance or an accommodation due to a disability for any part of the recruitment process, please contact our reception desk by phone at +1 (920) 502.3009 or our talent acquisition team by email corporatetalentacquisition@oshkoshcorp.com.

Oshkosh Corporation is an Equal Opportunity and Affirmative Action Employer. This company will provide equal opportunity to all individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Information collected regarding categories as provided by law will in no way affect the decision regarding an employment application.

Oshkosh Corporation will not discharge or in any manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with Oshkosh Corporation's legal duty to furnish information.

Certain positions with Oshkosh Corporation require access to controlled goods and technologies subject to the International Traffic in Arms Regulations or the Export Administration Regulations. Applicants for these positions may need to be "U.S. Persons," as defined in these regulations. Generally, a "U.S. Person" is a U.S. citizen, lawful permanent resident, or an individual who has been admitted as a refugee or granted asylum.

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 Advanced Electronic Solutions' has an exciting opportunity as a Quality Compliance Manager.  The Quality Compliance Manager is responsible to oversee and manage Teledyne Advanced Electronic Solution Compliance Program as defined in the company’s Quality Management System (QMS) policies, processes and procedure, functioning as an independent and objective body that reviews and evaluates compliance issues/concerns within the organization, and to ensure that the system in compliance with all applicable customer, AS9100D, AS9145, APQP and regulatory requirements.

Detailed Description:

• Responsible for the internal quality audit program.
• Conduct and support internal quality audits to ensure conformance to AS9100 and other applicable standards.  Audits encompass both Program and Operations activities.
• Manage AS9100 Registrar system by tracking and assisting corrective action process for findings from audits.  
• Oversight of the AS9100 certification of the TAES Lewisburg Site
• Facilitate 2nd and 3rd Party compliance audits.
• Facilitate Customer audits and survey.
• Track, Manage, and drive aged CAR ,SCAR, and audit action list.
• Facilitate, orchestrate teams, and complete government audit.
• QMS coordination with Corporate Teledyne Brown Huntsville QMS team.
• Administer and manage TAES documents for the site by ensuring they are maintained and being followed by the business. 

Requirements:

• Typically requires a degree in Science, Technology, Engineering or Mathematics unless prohibited by local laws/regulations and minimum 2 years prior relevant experience or an equivalent combination of education and experience as determined by TAES.
• U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract.
• Knowledge and experience with AS9100 / AS9145 / APQP are critical.
• Candidate should have substantial experience in preparation and managing 3rd party audits/auditors.
• Lead auditor experience or a certification in auditing is strongly preferred.
• Experience with root cause analysis.
• Ability and experience to mentor and guide others.

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:

Vertex is seeking a talented individual to join our Analytical Development – Process Analytics and Control group in Boston, MA.  As a member of the Process Analytics and Control team, this individual will also be a member of the industry leading continuous drug product manufacturing team supporting drug development programs at Vertex.  The Process Analytics and Control team is responsible for the automated control strategy for drug product continuous manufacturing and the development/validation of PAT methods.  Specifically, the role will focus on development and maintenance of process analytical technology, the implementation of the automated control strategy, and the validation of Process Analytical Techniques (PAT) methods, automation, and data reporting.  

Key Duties and Responsibilities:

• Supporting GMP continuous manufacture, including leading PAC activities in support of clinical and commercial manufacturing
• Managing and coordinating activities related to qualification and maintenance of PAT equipment
• Leading the development and validation of automation control software related to continuous manufacturing.
• Developing a control strategy and implementing PAT methods (NIR, Raman, particle size) and data models to support manufacturing unit operations.
• Presenting to and aligning with cross functional teams on critical issues and solutions
• Authoring and reviewing documents required for a cGMP environment.
• Authoring, reviewing, and assessing quality events including change controls, deviations, and CAPAs
• Supporting inspections by regulatory agencies

Knowledge and Skills:

• Experience managing a team, coordinating resources and delivering results is essential
• The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects
• The ability to work successfully in both a team/matrix environment as well as independently i
• Excellent written and verbal communication skills as demonstrated by symposia presentations and research publications in peer reviewed journals
• Hands-on experience developing, integrating, and maintaining analytical or process instrumentation  

Education and Experience:

• PhD (physical sciences, mathematics or engineering) and 2+ years, or Master's and 5+ years, or Bachelor's and 8+ years or equivalent experience.

Company Information

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.

We empower the best people to help sustain our world. 100% employee-owned. Independence guaranteed.

Company:

Performs identification, inspection, and evaluation of trees and brush along utility lines and submits inspection results to clients with recommendations. Plans, directs, and coordinates the activities of assigned tree clearance crews. Discusses and negotiates line-clearance crew access issues, and serves as a liaison between clients, tree crews, and client customers.

Duties & Responsibilities

Essential Duties and Responsibilities:

• Patrols distribution and/or transmission circuits; prescribes work in accordance with client specifications, evaluates tree conditions for future trim cycles, property owner notification of work to be performed, tracks work progress, performs outage investigations, trouble orders, and, when necessary, coordinates work with public and private agencies.
• Enters tree trimming and tree and brush removal prescription into data collection platform.
• Perform audits on tree contractor to ensure compliance with prescribed work
• Responsible for accurately updating documents required for performance of work
• Maintain working relationships with local client personnel as well as all relevant federal, state and local governmental agencies
• Work must be performed in compliance with all regulatory requirements and client vegetation management standards.
• Attains certification as an Arborist through the International Society of Arboriculture upon eligibility.
• As requested by the Senior Utility Pre-Inspector or Manager, performs all necessary duties for emergency response in accordance with all safety requirements, law and regulations, and applicable labor agreements.
• Makes a positive personal impression on others. Adheres to attendance policies and faithful in coming when scheduled and conforms to work hour requirements.
• Conducts work in a safety-conscious manner as not to endanger themselves or others. Keeps the work area [office and/or company vehicle] neat, orderly, and professional in appearance. If applicable, ensures maintenance on company vehicles is done in a timely and efficient manner.
• Other duties as required.

Equipment, environmental and safety requirements:

• Driving cars, trucks, and/or All Terrain Vehicles (ATVs)
• Walking on uneven ground
• Exposure to excessive noise
• Exposure to extremes in temperature, humidity, or wetness
• Operation of foot controls or repetitive foot movement
• Exposure to dust, gas, fumes, chemicals
• Various forestry-related equipment, including but not limited to clinometer, range finder, logger’s tape, DBH tape and various safety-related equipment such as hard hat, safety vest, safety glasses, ear plugs, etc.

Qualifications:

Education and Experience Requirements:

• Must be 21 years of age or older
• ISA Certified Arborist
• Ability to work independently, strong verbal and written communication skills
• Ability to work in rugged terrain and inclement weather
• Map interpretation; preform data collection using various software platforms
• Valid Driver License and ability to drive and operate a 4x4 vehicle
• Basic use of Excel (sum, totals, simple formulas) and Outlook; proficient in Microsoft Word

Required Skills:

• Ability to identify local trees and knowledge of growth rates.
• Accountability: accepts personal responsibility for quality and timeliness of work.
• Accuracy and work quality: performs work completely, correctly, and in a professional manner.
• Adaptability and flexibility: meets the changing conditions and situations in work responsibilities.
• Creativity: possesses ability to develop and present new ideas and better ways of doing things.
• Dependability: is reliable and has the ability to do required jobs.
• Drive and achievement orientation: sets challenging goals for self and willingly puts in extra time and effort in crisis situations.
• Independence: possesses the ability to work autonomously with little supervision.
• Interpersonal skills: builds constructive and effective relationships.
• Positive attitude: displays optimism about the work to be done and demonstrates a positive attitude towards customers, peers, and the company.
• Quantity of work: generates adequate amounts of work based on the job requirements.

Supervisor Responsibilities:

• None

Working Conditions:

• 80% or more outdoors in various climate conditions
• Kneeling, crawling - occasional: sitting, standing, bending [waist], squatting, climbing,
• Lifting and carrying – occasional: 0-25 lbs; never: 26-100 lbs.
• Carrying – frequent: 0-10 lbs; occasional: 0-25 lbs; never: 26-100 lbs
• Heaviest item carried: Hand held computer weighing 2.5 lbs and/or maps with a clip board. Distance to be carried: Items are carried the entire time employees are walking in the field. Occasional: fire extinguisher and Indian pack for fire suppression.

Additional:

• Works with Inside Company:
  • All employees and managers
• Work with Outside Company:
  • Utility management and contract workforce
  • Customers
  • Local/agency officials as needed

Salary Range Disclaimer

The base salary range represents the low and high end of the Pacific salary range for this position. Actual salaries will vary depending on factors including but not limited to customer contact terms, location,  experience, and performance. Other rewards may include Paid Time Off, 401(k) retirement savings plan with company match, ESOP contributions, medical, dental, and vision insurance, and other region-specific benefits as eligible. 

Salary Range Transparency

For applicants residing in California, the salary range for this role is from $28.00 min to $ 36.00 max.

#LI-ACRT

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Title:

POSITION IS CONTINGENT UPON CONTRACT FUNDING

KBR has an opening for a Technical Professional – IT Information Assurance to join our team of qualified, diverse individuals onsite at NBVC Point Mugu, CA This position requires on site presence. Remote or Tele-Work is not available.
 

Roles and Responsibilities:

• Serves as an Information Systems Security Officer (ISSO) for Government information systems in support of a Program Management Activity (PMA).

• Performs extensive assessments of systems and networks within the networking environment or enclave and identify where those systems/networks deviate from acceptable configurations, enclave policy, or local policy; Candidate will achieve this through passive evaluations (compliance audits) and active evaluations (vulnerability assessments). 

• Establish strict program control processes to ensure mitigation of risks and supports obtaining certification and accreditation of systems; This includes process support, analysis support, coordination support, security certification test support, security documentation support, investigations, software research, hardware introduction and release, emerging technology research inspections and periodic audits.

• Assists in the implementation of the required government policy (i.e., RMF, NISPOM, JSIG) and makes recommendations on process tailoring. 

• Performs extensive analyses to validate established security requirements and to recommends additional security requirements and safeguards.

• Supports the formal Security Test and Evaluation (ST&E) required by each government accrediting authority through pre-test preparations, participation in the tests, analysis of the results, and preparation of required reports. 

• Periodically conducts a review of each system's audits and monitors corrective actions until all actions are closed.

Functional Job Description:

• Implement Risk Management Framework (RMF) in accordance with NIST SP 800, Joint Special Access Program Implementation Guide (JSIG).

• Participates in the development and maintenance of system security plans and contingency plans for all systems under their responsibility.

• Draft, maintain, Planned, System Security Checklists, Privacy Impact Assessments, POA&M, and Authority to Operate (ATO) artifacts.

• Develop Plan of Action and Milestones (POA&M) for identified vulnerabilities and ensure compliance through monthly / quarterly updates.

• Maintain inventory of all information Security System assigned.

• Develop a variety of Assessment & Authorization deliverables including; System Security Plan (SSP), Security Assessment Report (SAR), Contingency Plan (CP) and POA&M for review and approval for Authorization Official

• Monitor and conduct Security Control Assessment to ensure all controls meet security requirements as stipulated in the SSP, NIST SP 800-53, JSIG.

• Effectively communicate Technical Information to non-technical personnel

• Coordinate with Leadership across the organization to ensure timely compliance.

• Develop Waivers and exceptions for information system vulnerabilities.

Basic Qualifications:

• Master’s degree in computer and architecture information systems management or related field from an accredited college or university or equivalent experience is required. OR

• Twelve (12) or more years of combined experience performing duties as described. OR

• Bachelor’s degree and an additional four (4) years of relevant experience may be substituted for a master’s degree. OR

• Associate’s degree and an additional eight (8) years of relevant experience may be substituted for a Master’s Degree

• Two (2) years of experience with mid-sized client/server systems in systems analysis, software design, software development, and system administration is required.

• Experience with DoD M5205.07 Series, Risk Management Framework (RMF) and Joint SAP Implementation Guide (JSIG) requirements is required.

• Knowledge of quality assurance, quality control, and independent verification and validation techniques is required.

• Experience working independently and as part of a team in researching data, developing analytical techniques and methodologies is required.

• Experience with managing secure Information Systems (IS) and databases while implementing and maintaining cross-domain solutions is required.

• A current Information Assurance Manager (IAM) Level I certification in accordance with DoD 8570.01-M, or the ability to gain the IAM Level I certification within six months is required.

• Applicant selected may be subject to a government security investigation and must meet eligibility requirements for access to classified information.

• A current Secret Clearance is required.

Contract requirements regarding education and experience will prevail.

KBR is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law.

Business Unit:

Company Details:

Job Details:

Job Summary: The role has the dual responsibility to support the Government Compliance and Cost Accounting reporting requirements of the business. This position provides complex financial information and support to the operating unit’s management. The position also interfaces with government agencies such as DCAA and DCMA. Provides support for government audits and assists with maintaining compliance with government requirements including the Federal Acquisition Regulation (FAR) and Cost Accounting Standards (CAS). This position typically works under general supervision and direction. Incumbents of this position will regularly exercise discretionary and substantial decision-making authority

Essential Job Duties and Responsibilities:

* Participates in monthly accounting cycle

* Calculates monthly revenues and profits for subsidiary based on program performance

* Analyzes bookings and backlog based on contractual agreements

* Accurately reports status of actuals against plan and advises management regarding significant overruns

* Coordinates project plans with the Program Financial Operations (PFO) department and consolidates information by product line.

* Preparation of the annual Incurred Cost Proposals

* Updates Disclosure Statements

* Performs internal timekeeping audits

* Supports DCAA and DCMA audits

* Assists all levels of management in the determination of any policy changes that affect the financial performance of the operating unit

* Hybrid position with 3 days in-office weekly. #LI-hybrid

Minimum Job Requirements:

Four-year college degree in accounting, or equivalent, plus a minimum of four years related experience. Experience with DCAA/DCMA audit and government compliance. Must communicate effectively, both verbally and in written form, with all levels of employees including upper management. Must be competent with personal computer and be familiar with spreadsheet software (e.g., Lotus 1-2-3, EXCEL) and other Microsoft Office software. Ability to follow written and verbal directions. Ability to prioritize, complete multiple tasks, and work under deadlines. Able to concentrate, focus, and perform analyses. Adept analytic and numeric skills required. Must be able to work at a computer for extended periods of time.

The description provided above is not intended to be an exhaustive list of all job duties, responsibilities and requirements. Duties, responsibilities and requirements may change over time and according to business need.

Cubic Pay Range San Diego only:

$75,000-110,477 + benefits.

The Cubic pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

Worker Type:

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