Quality Control Specialist, Microbiology

About This Role

This Quality Control Specialist role provides technical and operational leadership for the QC Microbiology and Environmental Monitoring laboratories. The specialist will lead microbial identification activities, environmental monitoring investigations, and laboratory operations in a highly dynamic, team-oriented environment.

Responsibilities

• 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)
• Partner with Quality, Manufacturing, Engineering, and global microbiology teams to support process improvements, operational excellence initiatives, regulatory inspections, and strategic microbiology projects

Requirements

• High school diploma / GED and 10 years of Quality, Microbiology or Operations experience OR Associate’s degree and 8 years of Quality, Microbiology or Operations experience OR Bachelor’s degree and 4 years of Quality, Microbiology or Operations experience OR Master’s degree and 2 years of Quality, Microbiology or Operations experience OR Doctorate degree

Nice to have:

• Microbiology degree and/or microbiology laboratory experience associated with microbial identification
• Demonstrated leadership experience, including coaching and developing staff, prioritizing laboratory workloads, and supporting routine and non-routine microbiological testing
• Understanding of manufacturing processes

About the Company

Amgen has helped pioneer the world of biotech since 1980 in its fight against the world’s toughest diseases. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—it reaches millions of patients each year, advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity-related conditions.