QC Microbiology Analyst: GMP Lab Data & Troubleshooting

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 55,000 - 75,000; 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, drug products, and materials under minimal supervision. The role requires a bachelor’s degree in a scientific discipline with GMP QC microbiology experience preferred; responsibilities include data management, protocol execution, and participation in CAPAs.

Join a team dedicated to biopharmaceutical development and the future of medicine, with

Qualifications

• Bachelor’s degree in a scientific discipline required with 0-1 years’ experience.
• BS in Microbiology, Chemistry, Biochemistry, or Biology preferred.
• 2+ years GMP QC Microbiology experience preferred.
• Experience with compendial test methods (Bioburden, Endotoxin, sterility) preferred.
• Ability to troubleshoot and maintain lab equipment.
• Experience with MALDI or MicroSeq systems is a plus.

Responsibilities

• Supports environmental and utilities monitoring sample collection.
• Coordinates testing materials and supplies to ensure timely testing.
• Performs advanced microbiology testing for Bioburden, Endotoxin, and sterility.
• Reviews lab data for accuracy and regulatory compliance.
• Assists with CAPAs and deviation investigations.

Skills

Lab troubleshooting

Quality systems

Data analysis

Education

Bachelor's degree in scientific discipline

BS in Microbiology, Chemistry, Biochemistry, Biology

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, drug products, and materials under minimal supervision. The role requires a bachelor’s degree in a scientific discipline with GMP QC microbiology experience preferred; responsibilities include data management, protocol execution, and participation in CAPAs.

Join a team dedicated to biopharmaceutical development and the future of medicine, with