Sr Associate Quality Assurance – Inspection PQA (3rd shift)

Join Amgen’s Mission of Serving Patients 
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. 

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. 

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 

Sr Associate Quality Assurance – Inspection PQA (3rd shift)

What you will do
Let’s do this. Let’s change the world. In this vital role Amgen is looking for mission-driven, detail-oriented professionals to join our Quality Assurance team at the AML Inspection facility. You’ll provide QA support in a Non-Standard Shift Operations environment that may include weekends and/or nights ensuring products meet the highest standards of compliance, safety, and quality. 

Key Responsibilities:

• Provide quality oversight of the inspection area for vials and syringes.
• Provide on-the-floor support and batch record review (e.g., MPs, MSRs).
• Conduct certification of standards for NPIs/PD Optimization.
• Conduct certification of Training Panels at the Training laboratory.
• Identify and help resolve discrepancies and compliance issues using the DAI model.
• Provide support during audits and regulatory inspections of AML 1 Inspection Operations as needed.
• Provide support for deviations and records.
• Collaborate with cross-functional teams to drive GMP compliance.
• Support QA activities typically performed by Associate-level roles when needed.

What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Sr. Associate Quality Assurance professional we seek is an individual contributor with these qualifications.

Basic Qualifications:
Master's 
Or
Bachelor’s + 6 months of Quality work experience
Or
Associate’s + 2 years of Quality work experience 
Or
High school/GED + 4 years of Quality work experience 

Preferred Qualifications:

• Ishihara certification
• Educational background in Life Sciences or Engineering
• Working knowledge of GMP regulations and ability to apply them in day-to-day operations
• Experience working in Inspection & Packaging
• Experience with data trending, technical writing, and documentation review
• Problem-solving approach with the ability to support investigations and recommend improvements
• Strong verbal and written communication skills
• Intermediate proficiency with Microsoft Office (Word, Excel, PowerPoint, databases)
• Strong time management and task prioritization skills in a fast-paced environment
• Flexibility to support non-standard shifts, including weekends
• Commitment to Amgen’s values and a quality-first culture

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. 
In addition to the base salary, 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: 

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance 
• 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 an annual site shutdown
• Flexible work models, including remote work arrangements, where possible

Apply now and make a lasting impact with the Amgen team. 
careers.amgen.com

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As an organization dedicated to improving the quality of life for people around
the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 

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.