Quality Assurance Associate III
Core
Executes QA activities and reviews GMP documents for downstream manufacturing and equipment to ensure product safety, efficacy, and purity at a new Large-Scale Manufacturing facility.
Role type
Quality Assurance Associate III (Downstream Operations)
Builds
Commercial, clinical, and PPQ campaigns for Biogen products
Domain
Pharmaceutical manufacturing (Downstream)
Required skills
GMP compliance, deviation management, equipment qualification, batch record review, change control, CAPA handling
Preferred skills
Downstream process knowledge, equipment qualification experience
Technologies
Electronic batch record systems, P&IDs, qualification protocols
Responsibilities
Review and approve GMP Engineering and Manufacturing documents; Partner with cross-functional teams for deviation management; Monitor and release Column Packing/Unpacking and Chromatography; Ensure adherence to procedures during manufacturing and CAPEX/OPEX projects; Participate in batch record review and close out for release
Seniority
Mid-level IC
