Quality Control Specialist, Microbiology

Responsibilities

• Provide technical and operational leadership for QC Microbiology and Environmental Monitoring laboratories.
• Lead microbial identification activities, organism assessments, and support routine and non-routine microbiological testing.
• Own and lead complex microbiological investigations, deviations, environmental monitoring excursions, and contamination events.
• Perform root cause analysis, risk assessments, and product impact assessments.
• Author and drive CAPAs, microbial risk assessments, and change controls to ensure compliant resolution of quality events.
• Coordinate contract laboratory activities, including testing support and data review.
• Maintain accurate, inspection-ready documentation using electronic systems such as LIMS, LMES, and Veeva.
• Partner with Quality, Manufacturing, and Engineering teams to support process improvements and regulatory inspections.

Requirements

• High school diploma / GED and 10 years of Quality, Microbiology, or Operations experience; OR
• Associate’s degree and 8 years of relevant experience; OR
• Bachelor’s degree and 4 years of relevant experience; OR
• Master’s degree and 2 years of relevant experience; OR
• Doctorate degree.
• Experience in a microbiology laboratory environment.
• Experience working within a GMP laboratory.
• Strong technical writing skills for documentation and investigations.

Preferred Qualifications

• Microbiology degree and/or specific experience with microbial identification.
• Demonstrated leadership experience, including coaching staff and prioritizing workloads.
• Experience supporting regulatory inspections and audit readiness.
• Proficiency with electronic quality systems (SAP, LIMS, LMES, CIMS, Veeva).
• Experience with aseptic sampling and laboratory equipment maintenance.
• Ability to manage Operational Excellence initiatives such as 5S and Standard Work.

Benefits

• Comprehensive health and welfare plans, including medical, dental, and vision.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.

About the Company

Amgen is a leading biotechnology company dedicated to discovering, developing, and manufacturing innovative human therapeutics. Since 1980, Amgen has focused on serving patients living with serious illnesses across oncology, inflammation, general medicine, and rare diseases.