Hiring: Specialist 2, Quality Assurance Technical Company: FUJIFILM Biotechnologies Location: Durham, NC Job Posted Time: 2026-09-16 14:04:18 Employment Type: Hybrid Target Skills & Keywords : Change Management, Microsoft Office, SAP, Stakeholder Management About the job Experience: •5+ years applicable industry experience. Required Skills: •Execute QA disposition of GMP raw materials and consumables to support manufacturing schedules. •Update and manage material status and associated records in SAP. •Contribute to and review quality system records (e.g., deviations, change management, change controls) in TrackWise. •Perform quality impact assessments for investigations and supplier change notifications related to raw materials/consumables. •Partner cross-functionally with Warehouse, Supply Chain, QC Raw Materials, and Quality leadership to resolve issues, drive timely decisions, and maintain flow of materials. •Review and adhere to applicable SOPs and work instructions; identify and support procedural improvements. •Uphold data integrity and ensure compliance with 21 CFR Part 820 and Part 11, and internal quality standards. •Quality systems (investigations, change control), data integrity, problem solving, conflict resolution. Qualifications: •High School Diploma or equivalent with 9+ years applicable industry experience; OR Associate’s degree with 7+ years; OR Bachelor’s degree with 5+ years; OR Master’s degree with 3+ years. •Applied hands-on capability in SAP (material status/transactions) and Microsoft Office. •Strong written and verbal communication, organization, critical thinking, and attention to detail. •Demonstrated ability to multitask, prioritize, and meet timelines in a GMP environment. •Bachelor’s degree with 5+ years applicable industry experience. •TrackWise experience for deviations and change management. •Supplier quality and/or material control experience in a regulated manufacturing environment. •Proven ability to influence and collaborate across Supply Chain, QC, and QA. •9+ years applicable industry experience; OR Associate’s degree with 7+ years; OR Bachelor’s degree with 5+ years; OR Master’s degree with 3+ years. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!