Quality Assurance Manager
4 days ago
Job Summary:
The QA Manager is responsible for overseeing the daily functions of the quality system at PCI Pharma Services. This includes direct supervision of Documentation Control, QA Associates, and Trainer, as well as backup and support for their activities.
Key Responsibilities:
- Work directly with the Sr. Director, Quality on continuous improvement activities.
- Ensure client specifications are met during materials receipt, Drug/Device processing, and final product shipment.
- Ensure procedures are followed and quality standards are met.
- Collaborate with the Sr. VP of Quality to evaluate products and materials for compliance to specifications.
- Oversight of established quality systems, including Document Control, CAPA, Deviation, Environmental Monitoring, Change Control, Complaint, Calibration, Documentation, Training, Component Control, Batch Record Review, Label Control, and Product Release.
- Review and approval of Validation Protocols (master and final reports).
- Approval of Deviations and CAPAs.
- Responsible for Environmental Monitoring and WaterTrend Reports.
- Provide QA Staff support, including scheduling updates and assignment of duties.
- Documentation Control prioritization, including document processing, batch record issuance, and change control issuance.
- Training, including issuing notifications for training needs, maintenance of training files, and initiating core training for new employees.
- Operations, including providing line clearances and documentation as needed.
- Product and Materials Records Review, including batch record review and release, materials review and approval, and calibration, water testing, environmental monitoring, temperature, and humidity review.
Requirements:
- University degree in a related science discipline with 7-10 years of experience in an FDA-regulated Pharma or Biotech industry.
- Prior supervisory experience.
- Excellent organizational skills, strong oral and written communication skills, detail-oriented, and ability to multi-task.
- Computer skills, including Excel, Word, Access, and PowerPoint.
About PCI Pharma Services:
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies, and programs, marketing approach, and workplace culture.
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