Quality - QA Specialist

The Quality Assurance Specialist will provide Quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing support. You will manage CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments and CMO product release. This position may also be cross trained to cover other QA functions as needed.
Responsibilities:
• Provides oversight for CMO Batch Production Records. Reviews executed Batch Records, GMP documents and prepare documentation for product release/disposition.
• Assists with Document Control and other QA functions.
• Coordinates and assist 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 ensure 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 working with other site groups.
• Ability to review Quality documents and ensuring 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.