The Quality Specialist provides quality oversight, GMP guidance and support for designated functional areas within Sharp Commercial sites.
Requirements
- Actively participate in non-conformance investigations
- Review and approve quality documentation
- Complete QMS actions related to change controls, non-conformance, complaints and CAPAs
- Support customer relationships related to Quality as needed
- Proactively identify and facilitate resolution of potential risks
- Implement methods for process control, process improvement, testing and inspection
- Ensure testing and inspection meet internal and external requirements
- Audit internal processes on shop floor and warehouse
- Perform periodic review of room / equipment logbooks and Master Packaging Records
- Author, review and / or approve quality documentation
- Provide Regulatory and Customer Audit Support
- Collect and distribute internal and Customer KPIs as required
- Assist with testing equipment calibration to ensure timely calibration and repair
- Support DEA requirements and DEA Compliance
- Verify Major/Minor cleans when required
- Proactive review of new quality inspection processes/procedures with operations and technical operations
- Perform In process inspections and AQL sampling as needed
- Support training department to implement new opportunities for training program
