Supervisor, Quality Control - Microbiology

FUJIFILM Holdings America Corporation; Northern (KY); Hybrid; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) plan

Paid vacation and company holidays

Job summary

FUJIFILM Biotechnologies is seeking a Supervisor, QC Microbiology to lead a team performing GMP testing, environmental monitoring, and microbiological control programs supporting clinical and/or commercial manufacturing.

The role emphasizes cGMP compliance, data integrity, and right-first-time performance, with opportunities to drive method robustness and CAPA-based improvements in a fast-paced facility.

Qualifications

• Bachelor’s degree in Life Science or Biology with 4+ years in a cGMP environment.
• Experience supervising QC Micro analysts with scheduling, training, and performance feedback.
• BioWork certificate is preferred.

Responsibilities

• Supervise and develop 6–12 QC Micro analysts; manage scheduling, training, and career development.
• Oversee environmental monitoring and utility programs; ensure compliant methods and data integrity.
• Review data, test records, LIMS entries, and COAs; ensure ALCOA+ data integrity.
• Lead QC deviations, OOS/OOT investigations, CAPA, and change controls.
• Partner with Manufacturing/Facilities on contamination control strategies and aseptic interventions.

Skills

People leadership

GMP testing

Data integrity

Environmental monitoring

Laboratory operations

LIMS/ELN

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in Life Science or Biology

Tools

LIMS/ELN

TrackWise

MS Office

Job description

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)

Company Overview

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

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 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 <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.

Minimum Requirements:

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

Preferred Requirements:

• BioWork certificate

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)

Benefits

Our programs are designed to focus on maintainingand enhancing all pillars of health with arobust 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 leading401(k) savings plan, insurance coverage, employee assistanceprograms and various wellness incentives. We support life-work balance withpaid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

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EEO Information

Fujifilm is committedto providing 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.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).