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

Role Description

FNZ Securities USA, headquartered in New York City, is a self-clearing broker-dealer which provides fully disclosed clearing and custody services to introducing broker-dealers and RIAs in the wealth management space. We are currently going through the application process with FINRA to become a licensed clearing broker-dealer and we expect to commence operations in 2024. 

This is an exciting opportunity for an experienced Anti-Money Laundering (AML) professional to join a newly formed U.S.  clearing broker dealer.  This venture represents FNZ’s entry into the U.S. fully disclosed clearing marketplace which is a key step in the firm’s strategic long-term growth strategy.  The role will include establishing and overseeing an AML program for a newly created brokerage clearing firm.

Reporting into the Chief Compliance Officer, this person will manage a team of AML professionals and overseeing all aspects of organizational compliance with AML laws and regulations, internal reporting and interactions with regulators and FNZ Global Risk and Compliance.  AML Officer will also work with vendors and IT providers to implement an effective technical infrastructure and will oversee all outsourced AML activities.

The AML Officer is responsible for compliance with all US related Anti-Money Laundering and Know Your Customer (AML-KYC) regulations and requirements and for implementation and administration of AML compliance program including internal controls, policies, procedures, training and testing the effectiveness of the program using industry standards and regulatory guidance.

Specific Role Responsibilities

• Develop and establish Policies and Procedures related to performing and updating the BSA/AML and OFAC Risk Assessments and its methodology.,

• Document and maintain the Policy and Procedures for the BSA/AML/OFAC Compliance Testing Program.,

• Develop scripts for the testing of business processes, procedures, and controls, both manual control processes and systems controls and maintain documentation and workpapers for examinations and reviews conducted.,

• Stays apprised of BSA/AML/OFAC legal and regulatory developments,

• Maintain effective communication with business unit and infrastructure leads assigned to understand BSA/AML and OFAC risks and internal control mitigants of each area.,

• Recommend for corrective action including policies, procedures and processes., Modifies scripts and/or scope based on initial findings.,

• Understands, monitors and incorporates the specific BSA/AML and OFAC risks and the mitigating internal controls relating to customers, products & services, and geographies for business/infrastructure units assigned.

• Oversee the review the program reporting provided by staff of the daily AML and sanctions compliance monitoring for account openings, KYC customer risk assessments and customer activity and financial transactions.

• Provide guidance to management and business unit partners on AML and sanctions compliance and regulation.

• Keep abreast of global regulatory updates and interpretive releases.

Experience Required

• Bachelor's Degree; Business, Finance, or equivalent field or equivalent work experience

• CAMS and CGSS designations.

• Must have at least 15 years work experience with a minimum of 10 years of direct experience in retail financial services, banking or industry-related investment compliance.

• Significant prior exposure to retail finance and banking operations and its related rules and regulations is required as is significant direct experience in a compliance-related function.

• Knowledge of current AML laws and regulations that affect the organization's policies (BSA/AML/PATRIOT), including any relevant New Hampshire Banking Department requirements.

• Knowledge of regulatory and compliance risk methodology and standards

• Must be proficient in MS Office (Outlook, Word, Excel, PowerPoint) and able to develop proficiency in our compliance systems as required to perform the duties of this position.

• Able to work overtime as necessary to keep current with work

About FNZ Culture 

Our culture is what drives us. It's at the heart of who we are and everything we do. It's what inspires, excites, and moves us forward. Our ambition is to create a culture for growth, one that opens up limitless opportunities for our employees, customers and the wider world. At FNZ we know that great impact is only possible with great teamwork. 

That’s why we value the strength and diversity of thought in our global team. 

The FNZ Way is the cornerstone of what we do. It is comprised of four values that set the standard for how everyone at FNZ interacts with each other, with our customers, and with all our diverse stakeholders around the world.

1. Care hard for customers and each other

2. Bring ambition to everything we do

3. Own it all the way

4. Work as one open team

Read more about The FNZ Way and our values: www.fnz.com/culture 

Opportunities

• Right from day one, you will work alongside exceptional, multicultural teams - experts in their respective fields - who will inspire and challenge you to make your greatest impact. 

• Be part of a highly successful, rapidly growing, global business that is leading the delivery of financial services via cloud computing and partners with some of the world’s largest companies;

• Working in a flexible and agile way that meets the needs of the business and personal circumstances; 

• Remuneration, significant financial rewards and career advancement is based on individual contribution and business impact rather than tenure or seniority;

• We provide global career opportunities for our best employees at any of our offices in the UK, EU, US, Canada, South Africa, and APAC.

Commitment to Equal Opportunities 

At FNZ, we recognise that diversity, equity and inclusion are important factors contributing to our success. We embrace the unique perspective and capabilities of our current and future employees, which will help us continue to drive innovation and achieve our business goals. Recruitment decisions at FNZ are made in a non-discriminatory manner without regard to gender, ethnicity/race, faith, age, nationality, gender identity, sexual orientation, marital status, socio-economic background, disability or military veteran status where all applicants and employees are valued and respected. 

In addition, we want to ensure accessibility needs are well supported, if you require specific support please advise us.

#LI-ES

About FNZ

FNZ is committed to opening up wealth so that everyone, everywhere can invest in their future on their terms. We know the foundation to do that already exists in the wealth management industry, but complexity holds firms back. 

We created wealth’s growth platform to help. We provide a global, end-to-end wealth management platform that integrates modern technology with business and investment operations. All in a regulated financial institution. 

We partner with over 650 financial institutions and 12,000 wealth managers, with US$1.5 trillion in assets under administration (AUA).

Together with our customers, we help over 20 million people from all wealth segments to invest in their future.

About JLG, an Oshkosh company

JLG began in 1969, when our founder, John L. Grove set out to resolve growing safety concerns in the construction industry. Since then we have been committed to understanding the challenges and delivering innovative solutions to the access market. We partner with customers to provide quality equipment, training opportunities and trusted support within the access industry. We are a global company, and our products—including mobile elevating work platforms, telehandlers, utility vehicles and accessories—can be found all over the world.

JOB SUMMARY:

The Quality Technician will be responsible for ensuring that every functional area is producing parts or products that meet the designed intent and fulfills a customer’s expectation regarding the performance of the machine they are purchasing; verify everyone is following the Standard Work outlined and report on any nonconformance. The Quality Technician will write reports and gather data not expected of assembly team members, communicate customer expectations, and confirm all functional testing has been completed and documented per JLG test procedures; verify the operational stability of all new product during startup and report out on the performance to engineering and Top Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

These duties are not meant to be all-inclusive and other duties may be assigned.

• Navigate the computer system programs utilized by department to develop and report on the quality of the process: MDS, EQC, LIRS, AS-400, QMS; articulate quality data and report to all levels of the business the current status of quality.
• Review of finished products for visual and functional issues prior to release and delivery to customer; work upstream in the process to problem solve issues found during audit and implement corrective action to prevent further issues.
• Understand how to interpret assembly, mechanical, electrical and hydraulic, prints and schematics; use inspection hand tools (go / no go, thread gauges, calipers, tape) to verify compliance.
• Understand the expectations of paint quality utilizing the A-B-C surface method and use basic paint inspection tools such as: surface finish gauge, thickness gauge, evaluate paint finish
• Verify that all items and/or assemblies manufactured comply with Engineering and Quality Control specifications, through all phases of the manufacturing process.
• Solve complex issues that drive customer satisfaction down; demonstrate the 8D tools (5 whys, is/ is not, fishbone, etc.) in order to properly and completely solve the problem and drive continuous improvement
• Understand basic weld symbols, their meaning and usage on a blueprint/drawing; be able to perform inspection for weld compliance using size weld gages, liquid penetrant, and magnetic particle.
• Ensure tools used by production are following calibration procedures and identify tool compliance and follow process if tools are found that are not in compliance of QMS.
• Partner with Supervisor and production team to provide exemplary customer service including process control and quality service while communicating quality updates/changes effectively to production.

MINIMUM QUALIFICATIONS:   

• High School Diploma or equivalent.
• One (1) or more years of relevant experience.
• Basic understanding of the theory and purpose of the calibration process.
• Ability to travel 10%.

PREFERRED QUALIFICATIONS:  

• American Society for Quality Certification program(s).
• Experience with quality systems (ISO9001, TS16949, AS9001).

WORKING CONDITIONS:

• Physical Demands: Frequent Hearing, Talking, Visual, Standing, Walking/Running, Reaching, Bending/Kneeling, Typing, Manual Dexterity; Occasional Sitting, Climbing, Driving, Upper Extremity Repetitive Motion, Lifting/Carrying up to 35lbs., Pushing/Pulling up to 30lbs.; Seldom Fine Dexterity.
• Non-Physical Demands: Frequent Analysis/Reasoning, Communication/Interpretation, Math/Mental Computation, Reading, Sustained Mental Activity (i.e., auditing, problem solving, grant writing, composing reports, etc.), and Writing.
• Environmental Demands: Frequent Work Alone, Task Changes, Tedious/Exacting Work, Temperature Extremes; Occasional High Volume Public Contact, Dust, Loud Noises; Seldom Physical Danger, Toxic Substances (i.e., solvents, pesticides, etc.).
• Work Schedule: Considerable irregularity of hours due to frequent overtime, weekend or shift rotation.
• Demands/Deadlines: Occasional stress due to deadlines or workload because of intermittent or cyclical work pressures, or occasional exposure to distressed individuals within the immediate work environment.

Oshkosh is committed to working with and offering reasonable accommodation to job applicants with disabilities. If you need assistance or an accommodation due to disability for any part of the employment process, please contact us at: 920-502-3009 or 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.

Looking for an opportunity to make an impact?

At Leidos, we deliver innovative solutions through the efforts of our diverse and talented people who are dedicated to our customers’ success. Everything we do is built on a commitment to do the right thing for our customers, our people, and our community. Our Mission, Vision, and Values guide the way we do business.

Your greatest work is ahead!

We are looking for a Substation Protection & Control Engineer to join our team. As an Career Protection & Control Engineer, candidates will have the opportunity to design substation protection and control projects for electric utilities at voltages from 12kV up to 500kV. This is an exciting and growing field in the power systems industry and allows candidates to get exposure to how the power generation such as that of renewable energy ties into the electric system. Candidates will be expected to use knowledge of digital logic design, AC and DC circuits to design substation electrical projects.

Remote Options Available for candidates located in one of the following states: (MA, MI, IL, ND, SD, PA, MN, CO, WA, OR, ID)

Successful candidates can look forward to a fast paced, diverse work environment and flexible work hours/work arrangements as well as managers who will encourage career development and growth including:  

• Engineer in Training Certificate (EIT).
• Professional Engineer License (PE).
• Project Management Professional (PMP).
• Technical & Non-Technical Training Opportunities.
• Leadership Opportunities.
• Mentorship & Training Opportunities.
• Opportunity to Lead, Grow, and Inspire a Dynamic Team

In this role, you can also expect to gain experience in the following:

• Interfacing with Local Clients.
• Partnering with a Variety of Utility Clients Nationwide.
• Working with different types of projects ranging from distribution to transmission level voltages.
• Electrical Power Calculations.
• Interactions with Other Disciplines (Substation, Telecom, and Civil Structural, etc).

Are you ready to make an impact? Begin your journey of a flourishing and meaningful career, share your resume with us today!

The Challenge:

• Relay One Line Design.
• Three Line AC Schematic Design.
• DC Protection Schematic Design.
• Panel Layout and Wiring Design.
• Develop Bill of Materials Based on Design Criteria.
• Quality Control Checks on Wiring Design.
• Complete Project Lifecycle Support from Scoping to Final Design and Implementation.
• Construction Support.
• Applying the Minimum Requirements of the National Electrical Safety Code to the Design Processes
• Working with Client Standards to Implement Design.
• Working with a Designer/Drafter to Create the Required Drawings for Each Project.

Successful candidates must comply with quality control and safe work practices and maintain compliance with project scope, schedule, and budget. This position will be a member of a design team comprised of engineers, designers, and CAD technicians and will work with client standards to implement design.

What Sets You Apart:

• Mid-Level: Bachelor’s degree in electrical engineering, or related degree with two (2+) or more years of Substation protection control design and/or field testing/commissioning experience.
• Senior-Level: Bachelor’s degree in electrical engineering, or related degree with four (4+) or more years of Substation protection control design and/or field testing/commissioning experience.
• Lead -Level: Bachelor’s degree in electrical engineering, or related degree with eight (8+) or more years of Substation protection control design and/or field testing/commissioning experience
• Experience in executing substation protection and control projects.
• Demonstrate Excellent communication skills and ability to interact with the internal team and clients to meet project needs.
• Ability to read and design substation protection and control drawings such as one-line drawings, three-line drawings, AC/DC schematic drawings and wiring design.
• Ability to meet deadlines under pressure situations.
• Collaborator and leader who can work effectively in team environment.
• Self-starter who works independently with minimal direction.
• Strong analytical skills and proven problem solver in both team and independent environments.
• High level of computer competency.
• Willingness to travel to project and/or client sites.

You Might Also have:

• US Citizen and able to pass a DOE Background
• Engineer Intern (“EI” or “EIT”) professional certification.
• Professional Engineer (“PE”) License.
• Experience performing quality control checks on small substation protection and control design projects.
• Experience working on CAD tools.
• Master’s degree in related field.
• Field testing/commissioning experience.

WHAT WE DO

Leidos is a trusted and technology-focused solutions provider. Utilities and mobile operators rely on our Power Delivery Services Team for reliable power and telecommunication expertise, as reflected through our work with more than 50 investor-owned utilities, more than 160 municipals/cooperatives, as well as a growing number of mobile operators, local utility providers and private developers. In addition to providing engineering and project management services, Leidos works with an established group of industry-leading construction partners delivering meaningful Energy Delivery Solutions. Our recognition as an industry leader is confirmed by the latest national rankings by Engineering News-Record (ENR) ranking Leidos within the Top 10 T&D Firms, and Top 10 Power Firms. To explore and learn more, click here! 

At Leidos, we deliver innovative solutions through the efforts of our diverse and talented people who are dedicated to our customers’ success. We empower our teams, contribute to our communities, and operate sustainably. Everything we do is built on a commitment to do the right thing for our customers, our people, and our community. Our Mission, Vision, and Values guide the way we do business.

We take care of our employees. Leidos seeks the best and the brightest, and in return, we invest in you, with an eye on your future, through career advancement, growth opportunities and continuous improvement via mentoring, formal and informal project management training and assistance with obtaining pertinent certifications. We challenge you to help solve some of the world’s toughest problems, and reward you with a welcoming culture that recognizes the importance of a strong work/life balance, as well as competitive compensation and benefits. We believe that diversity and inclusion make us all better and offer the chance to have fun and make a difference.

PowerDelivery

PDSSUBSTATION

Pay Range:

The Leidos 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.

About JLG, an Oshkosh company

JLG began in 1969, when our founder, John L. Grove set out to resolve growing safety concerns in the construction industry. Since then we have been committed to understanding the challenges and delivering innovative solutions to the access market. We partner with customers to provide quality equipment, training opportunities and trusted support within the access industry. We are a global company, and our products—including mobile elevating work platforms, telehandlers, utility vehicles and accessories—can be found all over the world.

JOB SUMMARY:

The Quality Technician will be responsible for ensuring that every functional area is producing parts or products that meet the designed intent and fulfills a customer’s expectation regarding the performance of the machine they are purchasing; verify everyone is following the Standard Work outlined and report on any nonconformance. The Quality Technician will write reports and gather data not expected of assembly team members, communicate customer expectations, and confirm all functional testing has been completed and documented per JLG test procedures; verify the operational stability of all new product during startup and report out on the performance to engineering and Top Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

These duties are not meant to be all-inclusive and other duties may be assigned.

• Navigate the computer system programs utilized by department to develop and report on the quality of the process: MDS, EQC, LIRS, AS-400, QMS; articulate quality data and report to all levels of the business the current status of quality.
• Review of finished products for visual and functional issues prior to release and delivery to customer; work upstream in the process to problem solve issues found during audit and implement corrective action to prevent further issues.
• Understand how to interpret assembly, mechanical, electrical and hydraulic, prints and schematics; use inspection hand tools (go / no go, thread gauges, calipers, tape) to verify compliance.
• Understand the expectations of paint quality utilizing the A-B-C surface method and use basic paint inspection tools such as: surface finish gauge, thickness gauge, evaluate paint finish
• Verify that all items and/or assemblies manufactured comply with Engineering and Quality Control specifications, through all phases of the manufacturing process.
• Solve complex issues that drive customer satisfaction down; demonstrate the 8D tools (5 whys, is/ is not, fishbone, etc.) in order to properly and completely solve the problem and drive continuous improvement
• Understand basic weld symbols, their meaning and usage on a blueprint/drawing; be able to perform inspection for weld compliance using size weld gages, liquid penetrant, and magnetic particle.
• Ensure tools used by production are following calibration procedures and identify tool compliance and follow process if tools are found that are not in compliance of QMS.
• Partner with Supervisor and production team to provide exemplary customer service including process control and quality service while communicating quality updates/changes effectively to production.

MINIMUM QUALIFICATIONS:   

• High School Diploma or equivalent.
• One (1) or more years of relevant experience.
• Basic understanding of the theory and purpose of the calibration process.
• Ability to travel 10%.

PREFERRED QUALIFICATIONS:  

• American Society for Quality Certification program(s).
• Experience with quality systems (ISO9001, TS16949, AS9001).

WORKING CONDITIONS:

• Physical Demands: Frequent Hearing, Talking, Visual, Standing, Walking/Running, Reaching, Bending/Kneeling, Typing, Manual Dexterity; Occasional Sitting, Climbing, Driving, Upper Extremity Repetitive Motion, Lifting/Carrying up to 35lbs., Pushing/Pulling up to 30lbs.; Seldom Fine Dexterity.
• Non-Physical Demands: Frequent Analysis/Reasoning, Communication/Interpretation, Math/Mental Computation, Reading, Sustained Mental Activity (i.e., auditing, problem solving, grant writing, composing reports, etc.), and Writing.
• Environmental Demands: Frequent Work Alone, Task Changes, Tedious/Exacting Work, Temperature Extremes; Occasional High Volume Public Contact, Dust, Loud Noises; Seldom Physical Danger, Toxic Substances (i.e., solvents, pesticides, etc.).
• Work Schedule: Considerable irregularity of hours due to frequent overtime, weekend or shift rotation.
• Demands/Deadlines: Occasional stress due to deadlines or workload because of intermittent or cyclical work pressures, or occasional exposure to distressed individuals within the immediate work environment.

Oshkosh is committed to working with and offering reasonable accommodation to job applicants with disabilities. If you need assistance or an accommodation due to disability for any part of the employment process, please contact us at: 920-502-3009 or 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.