Senior Specialist QAC Materials Management
Core
Support material qualification and release activities for biologic commercial and clinical pipelines at a manufacturing facility.
Role type
Senior Specialist, QA Compliance Materials Management
Builds
Qualified raw materials and consumables for biologic manufacturing
Domain
Biologics / Pharmaceutical Manufacturing
Required skills
Material qualification, QA compliance, cGMP knowledge, SAP, Change controls, Deviation management, Supplier investigations, CAPA management, TSE certification review
Preferred skills
Operational Excellence (5S, Kaizen, Problem Solving)
Responsibilities
Prepare and approve material qualification documentation; QA disposition of raw materials and consumables; Author and review QA procedures; Review change controls, deviations, supplier investigations, CAPAs, and supplier change notifications; Support Operational Excellence initiatives