Senior Specialist QAC Materials Management
Core
Support material qualification and release activities for biologic commercial and clinical pipelines at the Cruiserath manufacturing facility.
Role type
Senior Specialist, QA Compliance Materials Management
Builds
Biologic medicines for commercial and clinical use
Domain
Biologics manufacturing / Pharmaceutical
Required skills
Material qualification, cGMP compliance, QA procedures authoring, Change controls, Deviations/Investigations, Supplier Investigations, CAPAs, Supplier Change Notifications, TSE Certificates, SAP knowledge
Preferred skills
Material qualification, SAP
Responsibilities
Prepare and approve Material Qualification Documentation; Dispose of raw materials and consumables; Author and review QA procedures; Review change controls, deviations, supplier investigations, CAPAs, and SCNs; Support Operational Excellence initiatives (5S, Kaizen, etc.)
Seniority
Senior, hands-on IC