Specialist 2, Quality Assurance Technical
Overview
The QA Technical Specialist II at FUJIFILM Biotechnologies performs final disposition of GMP raw materials and consumables to ensure timely availability for manufacturing. This role serves as the QA point of contact for Warehouse, Supply Chain, and QC Raw Materials, resolving material-related issues and conducting quality impact assessments for investigations, change controls, and supplier change notifications.
External US
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.
Collaborate 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.