Position OverviewThe 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)
Job DescriptionWhat You'll Do: People Leadership
- 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.
GMP Testing and Lab Operations
- 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).
Investigations and Quality Systems
- 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.
Aseptic and Contamination Control
- 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.
Projects and Continuous Improvement
- 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).
Compliance and Inspection Readiness
- Ensure operations meet FDA/EMA/PMDA/MHRA, USP/EP/JP, ICH, and EU Annex 1 requirements.
- Host or support internal/external audits; maintain an inspection ready lab.
Knowledge, Skills, or Abilities:
- Environmental monitoring in ISO/Classified spaces and utilities testing.
- Sterility testing (e.g., USP ), endotoxin/LAL (USP ), bioburden/microbial limits (USP /), 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.
Minimum Requirements:
- Bachelor's degree in Life Science or Biology with at least 4 years of experience in a cGMP environment
Preferred Requirements:
Physical Requirements:- Will work in environment which may necessitate respiratory protection
- Ability to discern audible cues
- Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
- Ability to ascend or descend ladders, scaffolding, ramps, etc.
- Ability to stand for prolonged periods of time (240 minutes)
- Ability to sit for prolonged periods of time (240 minutes)
- Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers
- Ability to conduct work that includes moving objects up to 33lbs
- Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
- Will work in warm/cold environments (0-100F range)
BenefitsOur programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!
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To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
