Analyst, QC Microbiology

About the role

The Analyst, QC Microbiology is responsible for the key operational aspects of the QC Microbiology laboratory. This role performs microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples under minimal supervision. The Analyst, QC Microbiology is responsible for all activities associated with testing in accordance with written procedures. This role participates in writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff, as needed and in addition to regular work duties and assignments.

Company overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. The company is guided and united by its Group Purpose of "giving our world more smiles." Holly Springs, North Carolina combines small-town warmth with proximity to Raleigh's thriving tech scene.

Responsibilities

• Support environmental and utilities monitoring sample collection
• Provide input to define protocols for sample collection and logistics, ensuring compliance with regulatory standards
• Coordinate testing materials and supplies
• Plan and ensure materials are stocked; partner with procurement, inventory management, and distribution to optimize laboratory operations
• Perform advanced microbiology testing by generating complex test data for in-process samples, raw materials, and environmental samples, providing analysis for Bioburden, Endotoxin, and microbial findings
• Perform Sterility testing and validation processes; participate in isolator qualification procedures and ensure effective routine operations and maintenance
• Ensure accuracy and security of laboratory information, implementing tools and protocols for data management
• Conduct comprehensive reviews of laboratory testing results, provide analysis and interpretation of results, identify trends, and make informed recommendations
• Under the direction of management, troubleshoot issues with laboratory assays, identify underlying causes of assay failures, and develop strategic solutions to improve test reliability
• Lead general laboratory support and maintenance initiatives by maintaining analytical instruments and laboratory resources, coordinating purchases and receipt of essential supplies
• Support implementation and monitoring of CAPAs
• Partner with management to initiate and coordinate resolution for deviations and non-conformance events within quality systems
• Participate in project developments from concept through execution, ensuring alignment with organizational goals
• Perform additional duties, as needed

Minimum requirements

• Bachelor's degree in scientific discipline with 0-1 years of experience

Preferred qualifications

• BS in Microbiology, Chemistry, Biochemistry, or Biology
• 2+ years of intermediate experience in a GMP QC Microbiology Laboratory
• Knowledge of all compendial test methods (Bioburden, Endotoxin, sterility testing) preferred
• Ability to troubleshoot and maintain laboratory equipment and instrumentation
• Experience with microbial ID systems (MALDI, MicroSeq)