Manufacturing Quality Assurance Specialist II - 2nd Shift

Job description

POSITION TITLE: QA Specialist Level II REPORTS TO: (Manager’s title) QA Senior Supervisor DEPARTMENT: Quality Assurance LOCATION: Lexington FLSA Status (US Only): Exempt or Non-Exempt Please provide definitions for all acronyms. All fields must be completed. ROLE SUMMARY: Summarize the primary purpose and key responsibilities of the role. It may be helpful to complete this section after you have finished the other sections of the document. Responsible for on-shift support of manufacturing operations providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing and testing. Also responsible for review of controlled cGMP documentation and manufacturing records including any deviations or OOS that may have occurred during lot production. Participates during the release of raw materials, intermediates and final products. Performs internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities and keeps management informed on quality issues. ROLE RESPONSIBILITIES: In order of importance, indicate the primary responsibilities critical to the performanc...