Quality Control Supervisor, Microbiology

FUJIFILM Corporation

. Lead and supervise a team of 6–12 QC Micro analysts .

Posted 9/29/2026full-timeResearch Triangle Park • North Carolina • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading QC Micro teams, ensuring compliance with cGMP standards, and managing microbiological testing and environmental monitoring programs. Proficient in CAPA management, data integrity, and cross-functional collaboration to drive continuous improvement in laboratory operations.

Highest-signal resume keywords

Leadership in QC MicroCGMP ComplianceEnvironmental MonitoringCAPA ManagementLIMS/ELN Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Microbial TestingEnvironmental MonitoringSterility TestingEndotoxin TestingData TrendingDeviation InvestigationsRoot Cause AnalysisLean/Six Sigma ToolsRisk AssessmentsSOP Development

Soft Skills

Strong LeadershipPrioritizationCommunicationCross-Functional CollaborationDecision-Making

Tools & Technologies

LIMSELNTrackWiseMS OfficeTeams

Industry Keywords

CGMPALCOA+ICH Q7ICH Q9ICH Q10USPEPJPEU Annex 1ISO Classified Spaces

About the role

Key responsibilities & impact

Lead and supervise a team of 6–12 QC Micro analysts
Manage scheduling, training, performance feedback, career development, and team qualification matrices
Oversee environmental monitoring and utility programs, including viable/non-viable monitoring, compressed gases, WFI/PW, and clean steam
Ensure timely and compliant execution of compendial and in-house microbiology methods
Review and approve data, test records, LIMS entries, and COAs while ensuring ALCOA+ data integrity
Manage sample logistics, inventory, and equipment readiness, including calibration and preventive maintenance
Lead or approve QC Micro deviations, OOS/OOT investigations, environmental monitoring excursions, and product impact assessments
Author and implement CAPAs and change controls
Contribute to risk assessments, trend reports, stability/annual product review inputs, and APR/PQR
Maintain and improve SOPs, methods, and validation/qualification documents
Partner with Manufacturing, Validation, and Facilities on contamination control, 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 improvements using Lean/Six Sigma tools
Support or lead rapid microbiology method implementation, LIMS/ELN upgrades, and equipment qualifications (URS, IQ/OQ/PQ)
Ensure compliance with FDA/EMA/PMDA/MHRA, USP/EP/JP, ICH, and EU Annex 1 requirements
Host or support internal/external audits and maintain an inspection-ready laboratory

Requirements

What you’ll need

Bachelor’s degree in Life Science or Biology
At least 4 years of experience in a cGMP environment
Environmental monitoring in ISO/Classified spaces and utilities testing
Experience with sterility testing, endotoxin/LAL, bioburden/microbial limits, growth promotion, microbial ID, AET/MVT, and data trending
Deviation/OOS/OOT investigations, root cause analysis, and CAPA management
Familiarity with LIMS/ELN and TrackWise or similar eQMS
Proficiency with MS Office/Teams
Knowledge of 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
Ability to work in an environment that may necessitate respiratory protection
Ability to discern audible cues
Ability to inspect or perform tasks with 20/20 corrected vision and distinguish color
Ability to ascend or descend ladders, scaffolding, and ramps
Ability to stand and sit for prolonged periods of time (240 minutes)
Ability to perform repetitive motions involving wrists, hands, and/or fingers
Ability to move objects up to 33 lbs
Ability to bend, push or pull, reach materials from 18” to 60” in height, and use twisting motions
Ability to work in warm/cold environments ranging from 0–100°F

Benefits

Comp & perks

Medical, dental, vision, and prescription drug coverage
Health Savings Account with company contributions
Industry-leading 401(k) savings plan
Insurance coverage
Employee assistance programs
Wellness incentives
Paid vacation time
Paid sick time
Company holidays
Supportive environment focused on personal and professional growth