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Supervisor, Quality Control - Microbiology

FUJIFILM Biotechnologies · Triangle, NC · 6 days ago
On-siteAnalystFull-time

About the role

Leads a team of microbiology analysts to execute GMP testing, environmental monitoring, and microbiological control programs supporting clinical and/or commercial manufacturing. Ensures cGMP compliance, data integrity, safety, and right first-time performance, while driving method robustness, investigation quality, and continuous improvement. Typically supervises staff and junior scientists, manages day-to-day operations, and contributes to cross-functional initiatives of moderate complexity.

Responsibilities

  • 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.

Requirements

  • Bachelor’s degree in Life Science or Biology with at least 4 years of experience in a cGMP environment.
  • 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.

Preferred Qualifications

  • BioWork certificate.

Physical Requirements

  • 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 33 lbs.
  • Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
  • Work in warm/cold environments (0-100°F range).

Schedule

Wednesday – Saturday (7am – 5pm).

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, and various wellness incentives.
  • Paid vacation time, sick time, and company holidays.

About the company

FUJIFILM Biotechnologies leads the charge in advancing tomorrow’s medicines. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Our site is situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments: healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.”

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