Specialist QC

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

Let’s do this. Let’s change the world. In this vital role you will support analytical investigations ownership within the QC Technical Services team at Amgen.

Analytical Investigation Ownership

• Lead Quality Control analytical investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, and unexpected analytical results.
• Perform scientifically sound root cause analysis and develop effective corrective and preventive actions (CAPAs).
• Ensure investigations are completed accurately, on time, and in compliance with GMP requirements and internal quality standards.

Quality Systems & Risk Assessment

• Own and support deviations, CAPAs, and effectiveness verifications as assigned.
• Review and approve equipment-related change controls, as applicable.
• Partner with Quality Assurance to ensure investigation outcomes are risk-based and inspection-ready.
• May support additional project-based assignments as required.

Cross-Functional Collaboration

• Collaborate with Quality Control laboratories, Manufacturing, Process Development, Quality Assurance, Supply Chain, and other functional groups to resolve complex quality events.
• Facilitate effective communication among stakeholders to ensure timely investigation progression and issue resolution.
• Engage subject matter experts as needed to support technically complex investigations.

Inspection Readiness

• Support internal and external audits by clearly communicating investigation findings, root cause, and CAPA effectiveness.
• Maintain complete, accurate, and inspection-ready documentation.

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative teammate with these qualifications.

• High school diploma/GED and 10 years of directly related experience OR
• Associate's degree and 8 years of directly related experience OR
• Bachelor's degree and 4 years of directly related experience OR
• Master's degree and 2 years of directly related experience OR
• Doctorate degree

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or another Life Science discipline.
• 5–8+ years of Quality Control or Quality Assurance experience within the biotechnology or pharmaceutical industry.
• Demonstrated experience leading complex laboratory investigations, including OOS, OOT, atypical results, and laboratory deviations.
• Strong knowledge of GMP regulations, laboratory quality systems, and deviation management processes.
• Experience performing root cause analysis using structured problem-solving methodologies.
• Strong understanding of analytical laboratory techniques, instrumentation, and data integrity principles.
• Experience authoring and managing deviations, CAPAs, change controls, and effectiveness verifications.
• Ability to evaluate technical data, assess risk, and make sound, science-based decisions.
• Strong written and verbal communication skills with the ability to influence cross-functional teams.
• Experience supporting…