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 safety.
Role type
Senior Associate, Quality Assurance Operations
Builds
GMP-compliant pharmaceutical/biologics products
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Assurance in manufacturing)
Required skills
GMP compliance, batch record review, root cause analysis, regulatory investigations, global quality systems, document control, area walkthroughs, change management
Preferred skills
biologics manufacturing, drug substance manufacturing, Contract Manufacturing Organizations (CMO) experience, product disposition
Technologies
GxP regulations, Quality Management Systems (QMS), batch record systems
Responsibilities
Review and approve batch records for product release; conduct and analyze quality exceptions and investigations; manage controlled document workflows; perform area walkthroughs to identify compliance gaps; support GxP training and mentorship; assist in regulatory and third-party audits.
Seniority
Mid-level individual contributor with 4+ years experience