ROLE SUMMARYDevelops, directs and leads Quality Oversight of equipment and material preparation, aseptic compounding, filling and inspection at the Brentwood facility. In support of site wide objectives, coordinates support activities, reviews, audits and semi-finished product and component releases. Engaged with cross functional teams as needed to support continuous improvement activities, incident investigations and changes. Requires decision making ability related to Incident Investigation, Corrective and Preventive Actions with emphasis on overall quality, site priorities, results and achievements. ROLE RESPONSIBILITIESLead QA Team responsible for reviewing and documents related to production to ensure manufacturing and/or packaging of the product adhered to the approved record and in compliance with approved SOP’s and cGMPs.Understand the manufacturing operations and quality procedures for the area(s) to facilitate compliance to regulations.Assists and supports the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing and packaging operations.Participates in understanding failures and resulting CAPAs through notice of event reportsWorks closely with manufacturing, floor QA, shipping, P&I, Document Control and planning.Able to determine product acceptability and compliance with cGMP’s identify issues that may impact the product and compliance with regulations. Determines batch acceptability for further processing, reject or release Works independently, with minimal guidance and under short timelines while maintaining quality workAble to work in a team environment within own team and interdepartmental teams. Collects and reports dataParticipates in internal GMP audits and supports customer and regulatory auditsCollects, researches and analyzes dataAssists in review and editing of SOPs / Master Batch RecordsBASIC QUALIFICATIONSBachelor’s degree in a scientific/engineering discipline required.Minimum of three (3) years of cGMP, FDA regulated industry experience; prefer experience within the medical device or Quality Engineering settings. Minimum of one plus (1 ) years of experience with a Master’s degree acceptable.Knowledge of computerized systems (MS Office suite).Demonstrated ability to manage multiple priorities Professional certification is desirable but not required (i.e. CQA – Certified Quality Auditor, CQE – Certified Quality Engineer, SQE – Software Quality Engineer, etc.