Lead Microbiology QC Specialist - Drive Lab Quality

Amgen; Thousand Oaks (CA); In loco; USD 100.000 - 136.000; Tempo pieno

Descrizione del lavoro

Amgen is hiring a Quality Control Specialist, Microbiology in Thousand Oaks, CA. The role leads QC microbiology and environmental monitoring, overseeing microbial identification, investigations, and lab operations in a fast-paced GMP setting.

You will drive root cause analyses, CAPAs, and change controls, while ensuring compliant documentation in systems like LMES, LIMS, and Veeva. Collaboration with Quality, Manufacturing, and global teams is essential.

Competenze

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

Mansioni

• 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.

Conoscenze

GMP knowledge

Microbiology

Leadership

Environmental monitoring

Technical writing

CAPA

Formazione

Bachelor’s degree

Associate’s degree

Master’s degree

Doctorate degree

High school diploma / GED

Strumenti

LIMS

Veeva

LMES

CIMS

SAP

Maximo

Descrizione del lavoro

Amgen is hiring a Quality Control Specialist, Microbiology in Thousand Oaks, CA. The role leads QC microbiology and environmental monitoring, overseeing microbial identification, investigations, and lab operations in a fast-paced GMP setting.

You will drive root cause analyses, CAPAs, and change controls, while ensuring compliant documentation in systems like LMES, LIMS, and Veeva. Collaboration with Quality, Manufacturing, and global teams is essential.