reputed company - QA Specialist

Job reputed company: The reputed company Assurance Specialist will reputed company reputed company reputed company to the CMO with the ability to be on site up to support reputed company Reviews and QA Shop Floor manufacturing support. You will manage CMO reputed company for change management, deviation management, Annual Product reputed company reports, reputed company Agreements, Risk Assessments and CMO product release. This position may also be cross trained to cover other QA functions as needed. Responsibilities: Provides reputed company 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 reputed company 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 BMS reputed company standards. Ensures that reputed company audit items are resolved. Supports site for Inspection. Reviews any reputed company Events, CAPAs from reputed company audits to ensure that actions necessary to reputed company adequate confidence that the cGMP requirements are completed on time. Escalates critical reputed company problems to Senior Management in a reputed company manner. Qualifications BS in Life Sciences or equivalent with 5+ years reputed company experience reputed company a pharmaceutical or Biotechnology Company. Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations reputed company pharmaceutical or Biotechnology Company. Must be fluent in English language. Additional experience in an area allied with cGMP reputed company, reputed company 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 reputed company reputed company and working with other site reputed company. Ability to review reputed company 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 reputed company detail oriented and be reputed company to quickly detect errors reputed company documentation. Additional Sills: Apply tot his job Apply To this Job Apply tot his job Apply To this Job