THIS IS A 2ND SHIFT POSITIONThe Supervisor QA- Inspections is responsible for day-to-day operation of QA Inspections. He/She manages personnel and associated activities ensuring compliance with established regulations, product submission, and standard operating procedures governing the Warehouse, Manufacturing, and Packaging. Senior Manager QA - Inspections also manages hiring, developing, evaluating, and counseling of his/her staff. He/She provides feedback on a regular basis and prepares formal performance evaluations.
1. Manage the day-to-day activities of the QA Inspections Department. Establish work schedules and prioritize activities to meet FPI Cincinnati requirements. Ensure adherence to work schedules and project timelines.
2. Manage and effectively communicate the potential impact of QA activities in other departments.
Manage the following Quality Systems:
Production and Laboratory Audit Program
Incoming sampling (RM And Component)
New Drug Applications
Field Alert and Product Recalls
Product Quarantine and Release for Production
QM Master data
DEA Program Management
3. Direct investigations into all deviations, complaints, and OOSs as they pertain to the cGMP operations at the Cincinnati facilities. Ensure that investigations are completed in a timely manner. Ensure effective CAPAs are assigned. Review and approve/reject all investigations confirming conclusions are accurate, reflect the supporting data, and products are appropriately dispositioned/controlled.
4. Ensure GMP activities across the sites are compliant, sustainable, and are being followed.
5. Provide direction to QA, production, warehouse, and laboratory employees regarding interpretation of SOPs, regulatory guidance documents, and methods where instructions may not be clear.
6. Determine disposition of potentially nonconforming product and/or raw materials in the Warehouse, Manufacturing, and Packaging. Resolve supplier related quality issues.
7. Coordinate communication with internal and external QA departments (Forest and Suppliers/Partners) to ensure control and compliance of Forest products.
Experience: A minimum of 5 years of supervisory experience in the pharmaceutical or regulated healthcare industry.Licensure/Credentials:
No special requirements.
Knowledge, Skills, and Abilities: Incumbents must be detail-oriented, have the ability to prioritize multiple tasks, and demonstrate strong organizational and communication skills. The position requires thorough understanding of pharmaceutical cGMP compliance documentation requirements. The position requires proficiency in the use of Microsoft Word, Excel, Access, Power-Point, Outlook and Explorer. Knowledge of electronic systems for batch records and regulatory submissions is desirable.
Education: A bachelor’s degree in a related life science, technology, engineering or mathematics required. *LI-WK1