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
Biologic commercial portfolio and clinical pipeline products
Domain
Biologics / Pharmaceutical manufacturing
Required skills
Material qualification, cGMP compliance, QA procedures authoring, Change controls, Deviations/Investigations, Supplier Investigations, CAPAs, Supplier Change Notifications, TSE Certificates, SAP, Operational Excellence (5S/Kaizen)
Preferred skills
SAP knowledge, Material qualification expertise
Technologies
SAP
Responsibilities
Prepare, review, and approve Material Qualification Documentation; QA disposition of raw materials and consumables; Author, review, and approve QA-related procedures; Review and assess Biologics Manufacture documentation (Change controls, Deviations, Supplier Investigations, CAPAs, SCNs, TSE Certificates); Support Operational Excellence initiatives (5S, Standard Work, Kaizen, Problem Solving)
Seniority
Senior, hands-on IC