Quality Assurance Associate
Core
Manage qualification and lifecycle of external service providers and consumable vendors for commercial manufacturing, ensuring GMP compliance and quality governance.
Role type
Quality Assurance Associate (External Manufacturing & Vendor Qualification)
Builds
Quality Agreements, vendor qualification dossiers, and compliance oversight for outsourced manufacturing and testing.
Domain
Biopharmaceuticals / Biosimilars / Regulatory Quality
Required skills
GMP compliance, vendor qualification, quality risk assessment, deviation/investigation management, regulatory knowledge (FDA/EU/India), change control, audit participation
Preferred skills
Biosimilar product knowledge, cross-functional collaboration, analytical thinking, proactive problem solving
Technologies
GMP systems, quality management software, audit tools
Responsibilities
Conduct qualification audits of external manufacturing and testing partners; establish and maintain Quality Agreements; monitor quality events (deviations, CAPAs, complaints, OOS/OOT); perform quality risk assessments for outsourced activities; verify GMP records compliance; track vendor performance metrics.
Seniority
Mid-level, hands-on IC
