Quality Assurance Associate - Drug Substance
Core
Verify compliance for drug substance manufacturing and testing activities, ensuring consistent product quality and operational compliance within the regulatory framework.
Role type
Quality Assurance Associate (Drug Substance)
Builds
Drug Substance batches and cell banks
Domain
Biopharmaceuticals / Biosimilars
Required skills
GMP compliance, cell bank management, batch record review, deviation/CAPA management, audit support, SOP creation, validation review, ALCOA+ principles
Preferred skills
Biosimilars experience, regulatory knowledge (FDA/EU/India), shift flexibility
Technologies
LN2 tanks, freezers, GMP record systems
Responsibilities
Oversee Master and Working Cell Bank qualification and traceability; Review and approve Batch Production Records (BPRs), Master Formula Records, and SOPs; Monitor environmental conditions for cell bank storage; Manage deviations, CAPAs, and change controls; Support internal and external audits; Conduct spot checks for GMP compliance; Issue cell banks to manufacturing operations.
Seniority
Mid-level, hands-on IC
