Job Description

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.

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

What You’ll Do

• 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

Minimum 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

Preferred Requirements:

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

Working Conditions & Physical Requirements:

Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes

Ability to stand for prolonged periods of time. minutes)

No X Yes Daily up to 60 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240

Ability to sit for prolonged periods of time. minutes)

No X Yes Daily up to 120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No x Yes

Ability to operate machinery and/or power tools. x No Yes

Ability to conduct work that includes moving objects up to X pounds. No x Yes If yes, x 10 lbs. 33 lbs.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No x Yes

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).