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Quality Control Specialist, Microbiology

Amgen
Thousand Oaks, CA, United States
On-site

About this role

About the Role In this vital role, you will provide technical and operational leadership for the QC Microbiology and Environmental Monitoring laboratories, leading microbial identification activities, environmental monitoring investigations, and laboratory operations in a highly dynamic, team-oriented environment. What You'll Do

  • Lead microbial identification activities, organism assessments, and support routine and non-routine microbiological testing.
  • Provide leadership for microbiology laboratory operations, coordinate daily priorities, supervise laboratory staff, and support weekend laboratory operations.
  • Own and lead complex microbiological investigations, deviations, environmental monitoring excursions, and contamination events, including root cause analysis, risk assessments, and product impact assessments.
  • Provide technical expertise for environmental monitoring, bioburden control, microbial identification, contamination control strategies, and laboratory controls.
  • Author and drive CAPAs, microbial risk assessments, and change controls to ensure compliant resolution of quality events.
  • Coordinate contract laboratory activities, including testing support, data review, investigation collaboration, and approval of associated documentation.
  • Generate and maintain complete, accurate, and inspection-ready documentation using electronic laboratory and quality systems (e.g., LMES, LIMS, CIMS, and Veeva).

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