Field Quality Assurance Operations, Single Use Facility - (Chicago, IL)

Provide Quality assistance and oversight during start up of clinical manufacturing facility and manufacturing of clinical/commercial drug substance. Performs review and approval of records for the manufacture of in-process materials, drug substance and other GMP processes as required. Assists in the identification, generation and review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines. Responsibilities: 1. Assures all electronic and paper documentation, which requires QA review is in compliance with corporate as well as site procedures, regulations, and other industry guidelines. 2. Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs. 3. Performs walkthroughs of the manufacturing facility and applicable support areas documenting observations and points of concern. 4.