QA Manager, Investigations
An Innovative pharmaceutical company is currently seeking a QA Manager, Investigations to join its rapidly expanding team. This company was founded back in 2009, and already has had a tremendous amount of success in the generics space! This newly created position will give you the ability to join a company with tremendous amounts of growth potential. If you are looking to expand your career in QA then don't hesitate to apply!
The QA Manager, Investigations will have the following responsibilities:
- Release and Stability Program Oversight
- Manage all testing and reporting for release and stability results from multiple testing laboratories
- Complex deviation handling (review and approval) of temp excursions, OOT, OOS and laboratory investigations - trouble shooting skills necessary. Work closely with contract laboratories throughout investigation process (Phase I and Phase II) to closure
- Review and approve complex lab deviations in collaboration with the analytical support staff, ensuring proper impact assessment to product.
- Oversee new stability protocol review and approvals
- Test method change controls
- Support method transfer / technical transfer / validation activities with external business partners / CMOs.
- Documentation Review & Approval:
- Review and approve documentation such as Test Methods, Manufacturing Records, SOPs, Investigations, Change Controls, Validation Protocols and Reports, Equipment Qualifications and similar documents as directed by Quality Management.
- Perform Commercial Finished Product / Bulk Drug Product Release
- Execute the material release procedure(s). Manage commercial release priorities per business deadlines. Work directly with manufacturers and partners to resolve related questions/issues.
- File, retrieve, and maintain organized records
- Communicate with external business partners / CMOs regarding quality related issues and Quality Agreements.
- Track metrics for external business partners / CMOs on change controls, deviations, repeat deviations, product releases and rejections and other Third-Party Quality Key Performance Indicators.
- Review Annual Product Reports / Product Quality Reports.
- Change Management Program
The ideal candidate will have:
- Bachelor's degree in a technical field preferred.
- A minimum of 3-5 years' prior experience in a pharmaceutical investigations.
- Experience with injectable (sterile/aseptic) manufacturing / filling processes.