Quality Assurance Manager (Dayton)

JOB PURPOSE :

Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated.

KEY ACCOUNTABILITIES :

• Regular and predictable onsite attendance and punctuality.
• Directs the incoming and in-process QA groups. Makes final accept / reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner.
• Coordinates communication for status of incoming materials and resolves issues related to accept / reject disposition of materials.
• Coordinates communication of production status to next shift; attends daily update meetings as required.
• Manages personnel for in-process filling and inspection / packaging monitoring.
• Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required
• Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTRs, Commissioning Documents, FATs), engineering documents.
• Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements.
• Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials.
• Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and / or assures cGMP and technical training for and certification of staff.
• Places lots on HOLD if Quality issues are detected and notifies senior management.
• Assists the QA management in developing on department budget.
• Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions.
• Manages attendance records for all direct reports.

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What We Offer

Equal Opportunity Employer :

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.