Microbiologist Supervisor

Accentuate Staffing is partnering with a global leader in medical imaging and pharmaceutical manufacturing, in efforts to find a Microbiology Supervisor to support their Raleigh-based sterile manufacturing facility. This individual will play a key role in leading day-to-day microbiology lab operations, ensuring compliance with GMP standards, and supporting contamination control and product quality initiatives. This is an excellent opportunity for a senior microbiology professional looking to step into a leadership-focused role within a highly regulated, sterile environment.

Responsibilities

1. Lead and oversee daily operations of the QC Microbiology laboratory, including scheduling and coordination of testing activities
2. Perform and review microbiological testing including bioburden, endotoxin (LAL), sterility testing, environmental monitoring, and particulate testing
3. Execute and support method validation, equipment validation, and environmental monitoring programs
4. Lead investigations related to OOS, deviations, and contamination events, driving root cause analysis and CAPAs
5. Analyze and trend microbiological data to identify potential product quality risks
6. Author, review, and revise SOPs, protocols, and technical documentation
7. Train and mentor junior microbiology staff and ensure adherence to regulatory standards
8. Collaborate cross-functionally with Manufacturing, QA, Validation, and Engineering teams
9. Maintain audit readiness and support regulatory inspections (FDA, EU, etc.)

Requirements

1. Bachelor’s degree in Microbiology, Biology, or related degree
2. 5+ years of pharmaceutical microbiology experience in a GMP-regulated environment
3. Hands-on experience with:
4. • Environmental monitoring (cleanrooms, water systems)
   • Endotoxin testing (Kinetic LAL, Gel Clot)
   • Sterility testing (14-day)
   • Bioburden and filtration methods
5. Strong experience with aseptic techniques and cleanroom operations
6. Experience leading or mentoring team members in a lab setting
7. Knowledge of cGMP, GLP, FDA, and global regulatory requirements
8. Experience with investigations, CAPAs, and technical writing
9. Strong communication and cross-functional collaboration skills