QC Microbiology Analyst: Microbial Testing & GMP Ops

FUJIFILM Holdings America Corporation; Holly Springs (MS); On-site; USD 65,000 - 80,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is hiring an Analyst, QC Microbiology to perform microbial testing of in-process drug substances, products and materials with minimal supervision. You will generate data for Bioburden, Endotoxin and microbial findings and assist with sterile testing and validation.

The role includes documentation support, staff training, procurement coordination, CAPAs, deviations, and project timelines within the QC lab, requiring strong data management and

Qualifications

• Bachelor’s degree in scientific discipline with 0-1 years of experience.
• BS in Microbiology, Chemistry, Biochemistry or Biology preferred.
• Experience with microbial ID systems (MALDI, MicroSeq) is a plus.

Responsibilities

• Supports environmental and utilities monitoring sample collection.
• Coordinates testing materials and supplies for the QC microbiology lab.
• Performs advanced microbiology testing for Bioburden, Endotoxin and microbial findings.
• Conducts sterility testing and validation processes and supports isolator qualification.
• Reviews laboratory testing results and provides interpretation and trend analysis.
• Assists with CAPAs, deviations, and non-conformance events within quality systems.
• Provides training support and onboarding of new staff as needed.

Skills

Regulatory compliance

Data management

Troubleshooting

Team collaboration

Analytical thinking

Laboratory operations

Education

BS in Microbiology

Bachelor’s degree in science

Tools

MALDI

MicroSeq

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is hiring an Analyst, QC Microbiology to perform microbial testing of in-process drug substances, products and materials with minimal supervision. You will generate data for Bioburden, Endotoxin and microbial findings and assist with sterile testing and validation.

The role includes documentation support, staff training, procurement coordination, CAPAs, deviations, and project timelines within the QC lab, requiring strong data management and