Sr Associate I, Quality Assurance Operations
Core
Oversees strategic, tactical, and operational aspects of Quality Assurance at a biotech manufacturing facility, ensuring cGMP compliance and product quality.
Role type
Senior IC Quality Assurance Associate
Builds
GMP-compliant pharmaceutical/biologics products
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
GMP compliance, batch record review, CAPA management, root cause analysis, GxP regulations, document control, area walkthroughs, regulatory audit support
Preferred skills
Drug substance manufacturing, biologics, Contract Manufacturing Organizations (CMO), product disposition
Technologies
GxP systems, Quality Management Systems (QMS)
Responsibilities
Review batch records for compliance and product disposition; assess and investigate exceptions/CAPA; manage controlled document workflows; conduct area walkthroughs to identify compliance gaps; support regulatory and third-party audits; assist in implementing quality system improvements.
Seniority
Senior, hands-on IC
