We are PCI, a global company that pioneers and shapes the future of life-changing therapies. This Supervisor, Quality Assurance Internal Operations role leads QA Associates to ensure compliance with cGMP principles and guidelines. The position involves providing QA support, maintaining quality systems, and partnering with cross-functional teams to resolve quality issues.
Requirements
- Provide QA support for cGMP manufacturing operations
- Coordinate with cross-functional teams to continually improve procedures
- Support QA scheduling activities by monitoring production schedules and project management deliverables
- Lead Associates in providing QA on the floor oversight of manufacturing
- Maintain Quality Metrics for the company
- Review master and executed raw material records
- Direct involvement in supporting external client audits at PCI and regulatory inspections
- Obtain gown qualification for sterile manufacturing line clears
- Assist with Change Control, as needed
- Maintain and evaluate procedures and monitor new regulations
Benefits
- Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer