Specialist QC
Amgen
August 16, 2026
Remote friendly (West Greenwich, RI)
United States
Operations
Specialist QC
What You Will Do
Support analytical investigations ownership within the QC Technical Services team.
Responsibilities
- Lead Quality Control analytical investigations for OOS, OOT, atypical, and unexpected analytical results.
- Perform scientifically sound root cause analysis and develop corrective and preventive actions (CAPAs).
- Ensure investigations are completed accurately, on time, and in compliance with GMP 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 outcomes are risk-based and inspection-ready.
- Collaborate with QC laboratories, Manufacturing, Process Development, Quality Assurance, Supply Chain, and other groups to resolve complex quality events.
- Facilitate communication among stakeholders to ensure timely progression and resolution.
- Engage subject matter experts as needed.
- Support internal and external audits by communicating findings, root cause, and CAPA effectiveness.
- Maintain complete, accurate, inspection-ready documentation.
Basic Qualifications
- High school/GED + 10 years related experience OR Associate’s + 8 OR Bachelor’s + 4 OR Master’s + 2 OR Doctorate.
Preferred Qualifications
- BS in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences or related life science.
- 5–8+ years QC or QA in biotech/pharma; leading complex lab investigations (OOS/OOT/deviations).
- GMP, deviation management, structured root-cause analysis, analytical techniques/instrumentation/data integrity.
- Experience with deviations, CAPAs, change controls, effectiveness verification; risk evaluation and science-based decisions.
- Strong written/verbal communication; regulatory inspection support.
- Digital tools/data analytics/AI-enabled tech experience preferred.
Benefits
- Competitive benefits via Total Rewards Plan (health/welfare, retirement/savings, bonus/incentives, stock-based incentives, time off, flexible work where possible).
Application Instructions
- Apply at careers.amgen.com.
- No application deadline; continue accepting until a sufficient number/select a candidate.
What You Will Do
Support analytical investigations ownership within the QC Technical Services team.
Responsibilities
- Lead Quality Control analytical investigations for OOS, OOT, atypical, and unexpected analytical results.
- Perform scientifically sound root cause analysis and develop corrective and preventive actions (CAPAs).
- Ensure investigations are completed accurately, on time, and in compliance with GMP 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 outcomes are risk-based and inspection-ready.
- Collaborate with QC laboratories, Manufacturing, Process Development, Quality Assurance, Supply Chain, and other groups to resolve complex quality events.
- Facilitate communication among stakeholders to ensure timely progression and resolution.
- Engage subject matter experts as needed.
- Support internal and external audits by communicating findings, root cause, and CAPA effectiveness.
- Maintain complete, accurate, inspection-ready documentation.
Basic Qualifications
- High school/GED + 10 years related experience OR Associate’s + 8 OR Bachelor’s + 4 OR Master’s + 2 OR Doctorate.
Preferred Qualifications
- BS in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences or related life science.
- 5–8+ years QC or QA in biotech/pharma; leading complex lab investigations (OOS/OOT/deviations).
- GMP, deviation management, structured root-cause analysis, analytical techniques/instrumentation/data integrity.
- Experience with deviations, CAPAs, change controls, effectiveness verification; risk evaluation and science-based decisions.
- Strong written/verbal communication; regulatory inspection support.
- Digital tools/data analytics/AI-enabled tech experience preferred.
Benefits
- Competitive benefits via Total Rewards Plan (health/welfare, retirement/savings, bonus/incentives, stock-based incentives, time off, flexible work where possible).
Application Instructions
- Apply at careers.amgen.com.
- No application deadline; continue accepting until a sufficient number/select a candidate.