Senior Specialist – Contamination Control and Investigations
Amgen
August 19, 2026
Remote friendly (Holly Springs, NC)
United States
Operations
Senior Specialist – Contamination Control and Investigations
What You Will Do
- Advance the site Contamination Control Strategy and lead complex contamination-related investigations.
- Manage deviation investigations (microbial excursions, environmental/utility excursions, aseptic process deviations, contamination events, product quality investigations).
- Lead contamination control audit/inspection responses; develop risk-based remediation and ensure sustainable corrective actions.
- Support development/maintenance/continuous improvement of contamination control strategy; drive improvements to programs, risk assessments, and investigation processes.
- Lead inspection readiness and serve as contamination control SME; present strategies/outcomes/risk assessments to inspectors, auditors, and site leadership.
- Perform trend analysis (environmental monitoring, utilities, deviations, quality events); coordinate cross-functional teams and meet milestones.
- Identify systemic risks; partner with CCS network leads, QC Microbiology, Manufacturing, Engineering, Process Development, and Quality.
- Apply root cause analysis and quality risk management; provide structured science-based problem solving; develop investigation effectiveness metrics.
- Mentor investigators/operational personnel; act as site SME.
What We Expect Of You / Qualifications
Basic Qualifications:
- Doctorate + 2 years; or Master’s + 4; or Bachelor’s + 6; or Associate’s + 10; or HS/GED + 12 years directly related experience.
Preferred Qualifications:
- 7+ years in biotech/pharma with progressively increasing responsibility; strong contamination control/risk/investigations/quality systems/compliance.
- Science/Engineering degree (microbiology a plus); experience with contamination strategies and complex investigations.
- Knowledge of Annex 1, FDA, EMA, global GMP; Veeva QMS (deviations/CAPAs); regulatory audit experience; strong PM, communications, and cross-functional leadership.
Benefits
- Retirement/Savings plan, group medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off and bi-annual shutdowns; flexible work/remote where possible.
Application
- Apply now via careers.amgen.com.
What You Will Do
- Advance the site Contamination Control Strategy and lead complex contamination-related investigations.
- Manage deviation investigations (microbial excursions, environmental/utility excursions, aseptic process deviations, contamination events, product quality investigations).
- Lead contamination control audit/inspection responses; develop risk-based remediation and ensure sustainable corrective actions.
- Support development/maintenance/continuous improvement of contamination control strategy; drive improvements to programs, risk assessments, and investigation processes.
- Lead inspection readiness and serve as contamination control SME; present strategies/outcomes/risk assessments to inspectors, auditors, and site leadership.
- Perform trend analysis (environmental monitoring, utilities, deviations, quality events); coordinate cross-functional teams and meet milestones.
- Identify systemic risks; partner with CCS network leads, QC Microbiology, Manufacturing, Engineering, Process Development, and Quality.
- Apply root cause analysis and quality risk management; provide structured science-based problem solving; develop investigation effectiveness metrics.
- Mentor investigators/operational personnel; act as site SME.
What We Expect Of You / Qualifications
Basic Qualifications:
- Doctorate + 2 years; or Master’s + 4; or Bachelor’s + 6; or Associate’s + 10; or HS/GED + 12 years directly related experience.
Preferred Qualifications:
- 7+ years in biotech/pharma with progressively increasing responsibility; strong contamination control/risk/investigations/quality systems/compliance.
- Science/Engineering degree (microbiology a plus); experience with contamination strategies and complex investigations.
- Knowledge of Annex 1, FDA, EMA, global GMP; Veeva QMS (deviations/CAPAs); regulatory audit experience; strong PM, communications, and cross-functional leadership.
Benefits
- Retirement/Savings plan, group medical/dental/vision, life/disability, flexible spending accounts; discretionary annual bonus (or sales incentive); stock-based long-term incentives; time-off and bi-annual shutdowns; flexible work/remote where possible.
Application
- Apply now via careers.amgen.com.