Manufacturing Supervisor for Aseptic Filling Department

Led ongoing daily departmental activities for Aseptic Filling, Packaging and Label Store Supervised a team working in multifunctional capacitiesMaintained gowning qualifications and active floor presence in Aseptic Filling and PackagingAchieved safety, quality and production goals in an efficient, accurate and timely manner by working with Quality Labs, Quality Release, Aseptic Filling and Packaging personnelResolved production issues by working with Manufacturing and Quality Labs  personnel and escalating when necessaryHired and trained new employees as neededEvaluated direct reports through performance reviews and development plansDetermined merit raises of employeesEnforced work rules and adherence to Shire/Baxalta policiesCarried out disciplinary action as neededWas directly involved in QWT, Kaizen, Lean/5SInvestigated Events (non-conformances) and product complaints and implemented corrective actionsPerformed quality review of assigned Events and Product Impact Assessments Led in-plant audit ready status efforts for assigned areasAssisted others within the facility in understanding FDA, ISO and Baxter quality requirementsAssisted in implementation of Good Manufacturing Practices and Good Aseptic PracticesProvided guidance and coaching for less experienced individuals within the plantProvided quality oversight for retention samples for final product containers and intermediatesBack-up the assigned responsibilities of the Quality Management Inspection Manager on an as needed basis

Monitored product quality by performing visual and functional testingSupported the corrective and preventative action program by assisting with exceptionsIdentified quality and compliance gaps in the manufacturing areaVerification of manufacturing steps and techniquesReviewed in-process documentation for adherence to GDP and Standard Operating Procedures Created document changes in Standard Operating Procedures and official formsParticipated in various continuous improvement projects to reduce production time and improve documentation