Specialist QA - Quality System

HOW MIGHT YOU DEFY IMAGINATION?

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

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Specialist Quality Assurance – Quality Systems

Live

What you will do

Let’s do this. Let’s change the world. The Quality Management System (QMS) is the foundation that enables us to deliver on our mission to serve patients. In this vital role you will serve as Quality Assurance Specialist responsible for specific systems within the QMS at Amgen North Carolina. This position provides the opportunity to work directly with cross functional stakeholders, the Amgen global network, and the site Quality Leadership Team to implement, maintain, and improve critical systems such as Quality Risk Management, Documentation Management, Change Control, and Inspection Readiness.

Responsibilities:

• Drive implementation of Quality Systems in compliance to Amgen Standards and Regulatory expectations.
• Track implementation progress and monitor systems performance and report status in governance forums.
• Alert senior management of quality, compliance, and safety risks.
• Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, and training materials.
• Identify and lead implementation of continuous improvement opportunities.
• Serve as site SME for assigned Quality Systems, liaising with the global network for alignment and best-practice sharing and ensuring effectiveness, efficiency, and compliance at site.
• Lead and/or participate in inspection preparation and execution.
• Advise site on emerging trends and evolving expectations for assigned Quality Systems.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The strategic professional we seek is a strong communicator with these qualifications.

Basic Qualifications:

• High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Associate’s degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Bachelor’s degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Master’s degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
• Doctorate degree

Preferred Qualifications:

• Educational background in a science field.
• Experience with Quality Management Systems, including Deviations, Change Control, Document Management, and Risk Management.
• Understanding of regulations, standards and guidelines associated with Quality Management Systems.
• Strong organizational skills and demonstrated ability to drive projects to completion.
• Experience in monitoring performance and driving improvement.
• Demonstrated ability in problem solving.
• Capability to build strong and collaborative partnerships with stakeholders and partners and influence changes to ensure compliant, efficient, and effective operations.
• Experience participating in, managing, and responding to health authority inspections, partner and corporate audits.
• Excellent written and verbal communication skills.

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.

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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.