Quality Assurance Specialist - (Lexington, KY)

Quality Assurance Specialist - ( 190000JE ) Description JOB OVERVIEW The Quality Assurance Specialist ensures compliance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products. This position will support PPS? overall cGMP compliance and the day-to-day performance of cGMP compliance throughout the company. KEY RESPONSIBILITIES Coordinate resources for multiple projects, as assigned Assist in troubleshooting systemic GMP issues. Provide support for compliance/QA-related projects. Provide leadership within the department and in projects and systems that interface with other departments. Assist SR QA Specialist in process mapping and system analysis. Assist in ?on the floor? activities (line clearances, product inspection, interim issue solving, etc.) Assist in conducting GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations.