What are the responsibilities and job description for the QC Microbiologist manager position at GL Staffing?
We are seeking a QC Microbiology Manager with direct, recent, hands-on experience in sterile injectable (aseptic/fill-finish) manufacturing environments. This role is responsible for leading microbiology QC operations in support of aseptic production and ensuring full compliance with cGMP and regulatory requirements.
Location: Boca Raton, FL
Salary Range: $80,000 – $90,000 annually
Key Responsibilities:
- Lead QC Microbiology laboratory operations supporting sterile injectable manufacturing
- Oversee environmental monitoring programs for classified cleanroom environments (ISO 5–8)
- Perform and review testing including sterility, endotoxin (LAL), bioburden, and water systems
- Provide microbiological oversight for aseptic processing and fill-finish operations
- Review and approve deviations, OOS, CAPAs, and investigations related to microbiology
- Ensure compliance with FDA, cGMP, and USP <71>, <85>, <1116>, and related standards
- Support media fills, aseptic process simulations, and contamination control strategies
- Manage and develop microbiology staff
Minimum Qualifications
- Bachelor’s or Master’s degree in Microbiology or related field
- 5–7 years of QC microbiology experience in pharmaceutical manufacturing
- REQUIRED: Minimum 2–3 years of recent, hands-on experience in sterile injectable / aseptic fill-finish environments
- Strong working knowledge of environmental monitoring in cleanrooms
- Experience supporting aseptic processing and contamination control
Preferred Qualifications:
- Prior leadership or supervisory experience
- Experience with rapid microbiological methods
- Familiarity with LIMS systems
Salary : $80,000 - $90,000