Specialist - Client QA
Core
Provide quality assurance support for client projects, ensuring oversight of GMP manufacturing for cell banks, bulk drug substances, and finished drug products.
Role type
Specialist, Client QA Representative
Builds
Advanced therapeutic products including AAV and other viral vector-based therapies and vaccines
Domain
Biopharmaceuticals / Gene Therapies / CGMP Manufacturing
Deliverable
client delivery
Required skills
GMP knowledge, 21 CFR Parts 210/211, biological regulations, ICH Guidelines, EU GMPs, deviation review, change control management, batch record review, client communication, analytical troubleshooting, decision-making
Preferred skills
Biological manufacturing processes (cell banking, fermentation, purification, fill/finish), LIMS, Master Control, TrackWise
Technologies
TrackWise, Microsoft products, LIMS, Master Control
Responsibilities
Serve as primary point of contact for multiple clients; address client comments and concerns; review deviations and change controls; act as primary contact for client audits; participate in weekly QA-to-QA meetings; contribute to Master Batch Record review
Seniority
Specialist, entry to mid-level IC