• Perform raw material and product disposition
• Authorize lots for shipment
• Disposition SME for audits
• Present as Subject Matter Expert in Audits
• Approve NC investigations and CAPA records
• Approve change controls
• Review and approve BMS alarms
• Designee for QA Management on CCRB.
• Lead investigations.
• Lead site audits
• Own site quality program procedures and process
• Provide other Quality oversight and support as required.
• Doctorate degree & some manufacturing, quality, process development, clinical mfg, engineering experience
• Master’s degree & substantial manufacturing, quality, process development, clinical mfg, engineering experience
• Bachelor’s degree and substantial manufacturing, quality, process development, clinical mfg, engineering experience AND some managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Bachelor’s Degree in Life Sciences or related field or the equivalent combination of education and/or experience in related Quality Assurance or Manufacturing experience in the Pharmaceutical or medical device industry.