Manage and coordinate the Quality Assurance functionsManage and coordinate all company related safety programs and initiatives. Instrumental in reducing OSHA recordable incidents while increasing safety awareness in all job functions Promote, implement and maintain programs and processes in compliance with cGMPs, regulatory bodies and client requirementsIdentify strategic direction and policy development, promote and assess compliance with regulations, guidelines and SOPs as applicableImplement and promote quality initiativesTrained in the CFR Title 21 Assist with client audits, internal audits. Ensure commitments and timelines are metManage SOPs and forms preparation and maintenance within the business unitAssign Root Cause to Investigation Report.Investigate Discrepancies/Complaints and write investigation reportsEnsure Corrective/Preventative actions (CAPA) are closedManage the release of Clinical Trial Material and drug product to clinical sitesManage QC incoming inspectorsOversee the in-process inspectionsTrain new Quality Control/Quality Assurance personnelApprove and execute status change and expiry/retest datesInvestigate packaging deviationsProvide Quality support for packaging operationsManage the disposition and destruction of hazardous and non-hazardous materials