Position Overview
Job Title: QA Specialist II / Document Control AssociateJob Description
The QA Specialist II / Document Control Associate ensures that production processes remain client-focused, results-oriented, performance-driven, and fully compliant with applicable internal and external requirements. This role compiles batch record review records and batch disposition documentation to support Good Manufacturing Practice (GMP) operations and plays a key part in the manufacture and release of cell banks, bulk drug substances, plasmid products, and final drug products intended for human use.
Responsibilities
+ Provide quality assurance oversight and support to GMP manufacturing projects, working closely with QA Management to ensure effective QA coverage for the manufacture of master and working cell banks, bulk drug substance, plasmid products, and final drug product.
+ Support Manufacturing and Quality Control departments in performing and documenting deviations and failure in...