QC Microbiology Supervisor: Lead GMP Testing & Improvement

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

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.