Quality - QA Specialist

Responsibilities: Provides oversight for CMO Batch Production Records. Reviews executed Batch Records, GMP documents and prepares documentation for product release/disposition. Assists with Document Control and other QA functions. Coordinates and assists in timely review of documentation associated with manufacturing at CMO site. Assists with preparation for FDA and other regulatory agency audits and inspections. Provides daily summaries and follows the completion of CAPAs from audit findings. Gives guidance to CMO as needed and ensures CMO is compliant with Client Quality standards. Ensures that all audit items are resolved. Supports site for Inspection. Reviews any Quality Events, CAPAs from internal and external audits to ensure that actions necessary to provide adequate confidence that the cGMP requirements are completed on time. Escalates critical quality problems to Senior Management in a timely manner.

Qualifications: BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company. Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company. Must be fluent in English language. Additional experience in an area allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred. Ability to coordinate Quality oversight and work with other site groups. Ability to review Quality documents and ensure compliance to GMP. Documents to include batch records, logs, and others. Ability to be an effective communicator to Management and line staff. Ability to work with other manufacturing teams to implement business objectives. Must be very detail-oriented and be able to quickly detect errors within documentation.