Sr. Analyst 1, QC (All QC – 223 Shift
About The Position
The Sr. Analyst 1, Quality Control (QC) All QC Team is responsible for performing routine testing required for Urgent/STAT testing of manufacturing batch samples, clean utility, environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all of the QC laboratories required for urgent testing/Manufacturing support. The role will learn and perform testing/sampling across multiple labs in QC. 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.”
Requirements
- Bachelor’s with 2+ years of relevant QC 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 of QC testing and laboratory experience
- LIMS experience
- Experience with document control including reviewing and editing technical documents
Nice To Haves
- 4+ years of previous experience working within QC or with GXP or quality systems is an advantage
- Advanced experience in a GMP QC Laboratory, advanced knowledge of all compendial test methods.
Responsibilities
- Performs basic testing that spans all of the QC labs (e.g., Bioburden, Endotoxin, HPLC, UV280, TOC, etc.) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
