Supervisor, Quality Control - Microbiology

Fujifilm • Research Triangle Park, NC

13h • 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.

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

• Equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

What This Job Offers

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