GMP QC Microbiology Analyst: Bioburden, Sterility & Data

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (MS); On-site; USD 55,000 - 75,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks an Analyst, QC Microbiology to perform microbial testing of in-process drug substances, drug products, EM/UM, and raw materials. You will assist with documentation, training, and project timelines within a GMP environment.

Responsibilities include environmental monitoring, sample logistics, and competitor data analysis to ensure test accuracy and regulatory compliance.

Qualifications

• Bachelor’s degree in a scientific discipline.
• Experience in GMP QC Microbiology preferred.

Responsibilities

• Supports environmental and utilities monitoring sample collection.
• Provides input to define protocols for sample collection and logistics, ensuring regulatory compliance.
• Coordinates testing materials and supplies.
• Plans and ensures materials are stocked and partners with procurement to optimize lab operations.
• Performs advanced microbiology testing for Bioburden, Endotoxin, and microbial findings.
• Performs sterility testing and validation processes and participates in isolator qualification procedures.
• Ensures accuracy and security of laboratory data and implements data management tools.
• Reviews laboratory testing results and provides analysis and interpretation, identifying trends.
• Troubleshoots assay issues and develops solutions to improve reliability.
• Leads lab support and maintenance, coordinating purchases of essential supplies.
• Supports CAPAs and deviations within quality systems.
• Participates in project development from concept to execution.

Skills

Microbiology testing

Quality systems

Data management

CAPA

Troubleshooting

Education

Bachelor's degree in scientific discipline

Tools

MALDI

MicroSeq

Laboratory instrumentation

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks an Analyst, QC Microbiology to perform microbial testing of in-process drug substances, drug products, EM/UM, and raw materials. You will assist with documentation, training, and project timelines within a GMP environment.

Responsibilities include environmental monitoring, sample logistics, and competitor data analysis to ensure test accuracy and regulatory compliance.