Supervisor, Quality Control - Microbiology

Fujifilm • Research Triangle Park, NC

12h • Onsite

About The Position

The Supervisor, QC Microbiology leads a team of microbiology analysts to execute GMP testing, environmental monitoring, and microbiological control programs supporting clinical and/or commercial manufacturing. This role ensures cGMP compliance, data integrity, safety, and right first-time performance, while driving method robustness, investigation quality, and continuous improvement. The Supervisor typically supervises staff and junior scientists, manages day-to-day operations, and contributes to cross functional initiatives of moderate complexity. Shift: Wednesday – Saturday (7am – 5pm)

Requirements

• Environmental monitoring in ISO/Classified spaces and utilities testing.
• Sterility testing (e.g., USP <71>), endotoxin/LAL (USP <85>), bioburden/microbial limits (USP <61>/<62>), growth promotion, microbial ID (e.g., MALDI TOF), AET/MVT, and data trending.
• Deviation/OOS/OOT investigations, root cause analysis, and CAPA management.
• Familiarity with LIMS/ELN, TrackWise or similar eQMS; proficiency with MS Office/Teams.
• cGMP, data integrity (ALCOA+), ICH Q7/Q9/Q10, USP/EP/JP, and EU Annex 1 (2022).
• Strong leadership, prioritization, communication, and cross functional collaboration.
• Ability to operate in a fast paced, shifting priority environment and make sound, risk based decisions.
• Bachelor’s degree in Life Science or Biology with at least 4 years of experience in a cGMP environment.

Nice To Haves

• BioWork certificate

Responsibilities

• Supervise, coach, and develop 6–12 QC Micro analysts; manage scheduling, training, performance feedback, and career development.
• Maintain team qualification matrices; ensure training is current and effective.
• Oversee Environmental Monitoring/utility programs (viable/non-viable monitoring, compressed gases, WFI/PW/clean steam).
• Ensure timely and compliant execution of compendial and in-house methods: bioburden, endotoxin (LAL), sterility, growth promotion, microbial ID, total counts, AET/MVT, microbial limits, particulate testing, disinfectant efficacy, TOC/conductivity as applicable.
• Review and approve data, test records, LIMS entries, and COAs; ensure ALCOA+ data integrity.
• Manage sample logistics, inventory, and equipment readiness (calibration, PM).
• Lead or approve QC Micro deviations, OOS/OOT, EM excursions, and product impact assessments; author and implement CAPAs and change controls.
• Own or contribute to risk assessments (e.g., FMEA), trend reports, stability/annual product review inputs, and APR/PQR.
• Maintain and improve SOPs, methods, and validation/qualification documents.
• Partner with Manufacturing/Validation/Facilities on contamination control strategy, cleanroom behavior, gowning, cleaning/disinfection, and aseptic interventions.
• Support media fills, aseptic qualifications, and Annex 1 compliance initiatives.
• Drive throughput, right first time, and turnaround time (TAT) improvements using Lean/Six Sigma tools.
• Support/lead implementation of rapid micro methods, LIMS/ELN upgrades, and new equipment qualifications (URS, IQ/OQ/PQ).
• Ensure operations meet FDA/EMA/PMDA/MHRA, USP/EP/JP, ICH, and EU Annex 1 requirements.
• Host or support internal/external audits; maintain an lab inspection ready.

Benefits

• medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions.
• industry leading 401(k) savings plan
• insurance coverage
• employee assistance programs
• various wellness incentives
• paid vacation time, sick time, and company holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level