Lead QC Microbiology Supervisor – GMP Biopharma

BioTalent; Tustin (CA); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Health, dental, vision insurance

401(k) match

Paid time off

Job summary

BioTalent in California is seeking a Supervisor, Quality Control Microbiology to lead the QC microbiology team in a GMP biopharmaceutical setting. You will oversee environmental monitoring, sterility testing, bioburden, and growth promotion while driving investigations and CAPA implementation.

The role requires ensuring compliance with cGMP, USP, EP, and Annex 1, and entails mentoring staff and collaborating with global cross‑functional teams to deliver high‑quality biologic therapies.

Qualifications

• Bachelor's degree in Microbiology or related field.
• 5+ years of QC Microbiology experience in a GMP biopharmaceutical environment.
• Hands‑on experience with environmental monitoring, sterility, bioburden, growth promotion, and microbiological investigations.
• Strong knowledge of cGMP regulations, USP, EP, and Annex 1.
• Experience leading investigations, writing protocols/reports, and implementing CAPAs.
• Previous leadership or supervisory experience is highly preferred.

Responsibilities

• Lead QC microbiology testing, including environmental monitoring, bioburden, sterility, growth promotion, and Gram staining.
• Drive quality and compliance by leading OOS/OOL investigations, implementing CAPAs, reviewing protocols and SOPs, and ensuring compliance with cGMP, USP, EP, and Annex 1.
• Supervise and mentor the QC Microbiology team, provide training, and lead continuous improvement initiatives while partnering with cross‑functional teams.
• Work on impactful products in a regulated, high‑quality environment.
• Collaborate with cross‑functional global teams.
• Grow your career in a dynamic and innovative organization.

Skills

Leadership

GMP Knowledge

Environmental Monitoring

Investigations

CAPA Implementation

Education

Bachelor's degree in Microbiology

Tools

CAPA Systems

Job description

BioTalent in California is seeking a Supervisor, Quality Control Microbiology to lead the QC microbiology team in a GMP biopharmaceutical setting. You will oversee environmental monitoring, sterility testing, bioburden, and growth promotion while driving investigations and CAPA implementation.

The role requires ensuring compliance with cGMP, USP, EP, and Annex 1, and entails mentoring staff and collaborating with global cross‑functional teams to deliver high‑quality biologic therapies.