Sr Analyst , QC Microbiology

Position Overview

The Sr. Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures.

This role primarily works independently with minimal supervision as needed, consults with management on key decisions.

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.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

About This Role

• Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test
• Leads sample collection and manages sample logistics for testing
• Supports testing for all qualification and study directed testing
• Supports investigation of routine OOS assays and events
• Conducts qualification and validation protocols
• Leads sterility testing
• Reviews intermediate lab testing results
• Troubleshoots complex assays
• Writes and assists with document preparation and review
• Manages project timelines
• Assists management with training and on-boarding of new staff as needed
• Embraces LEAN lab and six sigma principles and applies them to laboratory processes
• Champions projects and project management as assigned
• Performs other duties, as assigned

Minimum Qualifications

• Bachelor’s with 2+ years of relevant Microbiology experience OR
• Master’s with 0 years of experience
  • Experience with aseptic production & support
• 1-3 years in a GMP environment
  • Advanced understanding of GMP, GLP, GDP requirements
• Advanced knowledge in Microbiology theory
• Advanced knowledge of Microbiology testing and laboratory experience
• LIMS experience
• Experience with document control including reviewing and editing technical documents
• LEAN lab and Six Sigma training and/or certification
• Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
• Intermediate LIMS software training
• Knowledge or training of FDA regulations (cGMP, cGLP, cGDP)

Preferred Qualifications

• Master’s with 1+ years of experience
• 4+ years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage
• Advanced experience in a GMP QC Microbiology Laboratory, advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing)
• Advanced experience with microbial , ability to troubleshoot complex equipment and instrumentation (MALDI, Micro Seq)
• Advanced LIMS / Trackwise software training
• Experience working within a QC laboratory environment, commissioning Pharmaceutical and/or laboratory facilities

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

PHYSICAL REQUIREMENTS PHYSICAL DEMANDS

Will work in environment which may necessitate respiratory protection X No Yes

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes

Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes

Ability to discern…