Supervisor, QC Raw Materials

Fujifilm•Research Triangle Park, NC

3d•Onsite

About The Position

The QC Raw Materials Supervisor leads the daily operations of raw material testing, release, and documentation to ensure materials meet specifications and regulatory requirements prior to use in manufacturing. This role manages a team of analysts/technicians, oversees sampling and testing workflows, ensures data integrity and GMP compliance, and partners cross-functionally with Quality Assurance, Supply Chain, Procurement, and Manufacturing. At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare. Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. 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: https://www.fujifilm.com/us/en/about/region/careers

Requirements

Bachelor’s degree in life science or related field with 4–6 years of relevant experience, including 1–3 years in a lead or supervisory capacity; OR Associate degree with 6–8 years of relevant experience, including 1–3 years in a lead or supervisory capacity; OR High School Diploma/GED with 8–10 years of relevant experience, including 1–3 years in a lead or supervisory capacity.
Relevant experience includes QC sample management, stability, cold-chain logistics, or GMP operations.
GMP/GDP fundamentals; data integrity.
Safety/HazCom; temperature excursion response.

Nice To Haves

Experience supervising non-exempt staff in a GMP QC environment.
Demonstrated experience with LabWare LIMS, FreezerPro, and TrackWise or similar QMS.
Experience supporting audits/inspections and owning deviations/CAPAs.
Continuous improvement certification (e.g., Lean/Green Belt) a plus.

Responsibilities

Lead day-to-day QC raw materials laboratory and sampling operations, ensuring safety, compliance, and on-time material release.
Build shift schedules and on-call coverage to support 24/7 manufacturing and QC testing needs.
Ensure training compliance, qualification, and adherence to GDP/CGMP and SOPs.
Ensure accurate, timely entries in LIMS (e.g., LabWare), FreezerPro, and controlled forms; own/approve logbook reviews and data checks.
Own or support deviations, investigations, CAPAs, and change controls related to raw materials, handling, and shipments.
Maintain inspection readiness; host/assist during internal/external audits and regulatory inspections for sample management scope.
Oversee sampling, inspection, and testing of incoming raw materials (chemical, excipient, API, packaging) per SOPs, compendial methods (USP/EP/JP), and internal specifications.
Manage workflows for CoA receipt and verification, material status control (quarantine/release/reject), ERP/LIMS transactions, and labeling.
Coordinate method verification/transfer/qualification for raw material tests (e.g., identification, assay, impurities, microbiology/bioburden, endotoxin, pH, FTIR/Raman, NIR, HPLC/GC, titration).
Partner with Supplier Quality on supplier qualification, incoming inspection plans, sampling plans (ANSI/ASQ Z1.4), and vendor monitoring.
Monitor lab and sampling area readiness (calibration, maintenance, qualification of equipment; environmental conditions; inventory of standards/reagents).
Track metrics and drive continuous improvement for cycle time, first-pass yield, and right-first-time documentation; implement lean/5S where applicable.
Support internal/external audits and regulatory inspections; provide responses and action plans.
Ensure proper handling, storage, and disposition of hazardous materials and waste per EHS requirements.
Support material lifecycle changes (spec updates, alternate suppliers, re-tests, re-qualification) and stability/hold-time studies as applicable.
Other job duties that may be assigned from time to time.