Quality Specialist (3rd Shift)

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