Supervisor, Quality Control - Microbiology

Position Overview

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)

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is 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 of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:

What 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 , 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  (e.g., MALDI TOF), AET/MVT, and data trending.
• Deviation/OOS/OOT investigations, root cause analysis, and CAPA management.
• Familiarity with LIMS/ELN, Track Wise 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,…