Specialist QC
About The Position
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. Specialist QC What you will do 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.
Requirements
- 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
Nice To Haves
- 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 regulatory inspections and responding to auditor inquiries.
- Experience utilizing digital tools, data analytics, or AI-enabled technologies to improve laboratory processes is preferred.
Responsibilities
- 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.
- 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.
- 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.
- Support internal and external audits by clearly communicating investigation findings, root cause, and CAPA effectiveness.
- Maintain complete, accurate, and inspection-ready documentation.
Benefits
- A 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
- Flexible work models where possible.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
