QA Specialist, Warehouse (Supply Chain)

FujifilmHolly Springs, NC
4d

About The Position

The QA Specialist, Warehouse (Supply Chain) is responsible for partnering in the Quality oversight of the Warehouse and Supply Chain area at FLBN. This role provides oversight of applicable processes and systems in both Warehouse (WH) and Supply Chain (SC) areas, with a focus on Quality attributes of the process. The QA Specialist ensures QA oversight of day-to-day activities and provides relevant QA input on the resolution or mitigation of operational issues as needed. 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. 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: https://www.fujifilm.com/us/en/about/region/careers

Requirements

  • Bachelor’s in Life Sciences or Engineering or equivalent with 2+ years of applicable experience OR Master’s in Life Sciences or Engineering or equivalent with 0 years of applicable experience
  • 1-3 years’ experience in a GMP environment

Nice To Haves

  • 5+ years of experience in GMP environment.
  • Experience working within a QA role in the pharmaceutical industry
  • Experience with TrackWise

Responsibilities

  • Provides on-the-shop-floor support for WH area in collaboration with WH personnel, e.g. walkthroughs, shipment related inspections and approvals and other tasks as assigned.
  • Review and approval of relevant WH and SC quality records, to include deviations, CAPAs, Change Controls (CMR), logbooks, and other records as assigned.
  • Author, Review and Approve documents in the relevant Electronic Document Management System (EDMS)
  • Review and Approve alarm notifications in WH area
  • Review and Approve Work Orders for WH/SC area as needed
  • Appropriately disposition material status in SAP for WH/SC areas
  • Performs other duties, as assigned
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