Quality Control Specialist, Microbiology

About the role

Join Amgens Mission of Serving Patients. 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.

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 Associates degree and 8 years of Quality, Microbiology or Operations experience OR Bachelors degree and 4 years of Quality, Microbiology or Operations experience OR Masters degree and 2 years of Quality, Microbiology or Operations experience OR Doctorate degree
• Demonstrated leadership experience, including coaching and developing staff, prioritizing laboratory workloads, and supporting routine and non-routine microbiological testing.
• Understanding of manufacturing processes associated with contamination control.
• Experience supporting regulatory inspections and audit readiness activities.
• Advanced technical writer who can articulate complex events into concise, clear, and contemporaneous documentation that is inspection ready.
• Professional work experience in a fast-paced, flexible GMP laboratory.
• Ability to generate, investigate, triage and close deviations and analytical test result assessments in Veeva.
• Ability to generate and document validation protocols and reports.
• Experience performing aliquoting of samples aseptically.
• Operation, maintenance experience with laboratory equipment.
• Ability to generate and revise methods and SOPs within CDOCs.
• Demonstrated proficiency with electronic systems capturing consumables, testing procedures, results, and investigations (SAP, LIMS, LMES, CIMS, Veeva, etc.).
• Demonstrated understanding and use of Maximo (Work Order System).
• Ability to manage and lead Operational Excellence initiatives including 5S and Standard Work associated with the testing labs.
• Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively.
• Demonstrated ability to be flexible and adaptable to support business needs.

Qualifications

• Microbiology degree and/or microbiology laboratory experience associated with microbial identification.

Skills

• Technical writing
• Leadership
• Environmental monitoring
• Microbial identification
• Contamination control
• Documentation creation
• Operational excellence

Benefits

See the benefits section on the Amgen careers website for details.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Schedule

Full time