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Click here or scroll down to respond to this candidateCandidate's Name
Burlington, NC Street Address EMAIL AVAILABLE PHONE NUMBER AVAILABLEWork ExperienceManufacturing Quality SupervisorKBI Biopharma - Durham, NCMarch 2022 to PresentBatch Record ReviewDeviation writing and InvestigationManufacturing Process QualityDirect Supervisor of 3 Quality Specialists.Quality/Training ManagerFXI Foam Technologies - High Point, NCFebruary 2020 to PresentPerform Quality checks on in Process and final Release ProductPerform Quality Investigation using Lean Six Sigma toolsCAPA PreparationWriting Quality Procedures (SOP)Updating MFG SOPsParticipate and Lead Process improvements in QA lab as well as Manufacturing floor.Power BIPowder Manufacturing Supervisor. Fluid Bed DryersHERBALIFE MANUFACTURING: TEANovember 2014 to December 2019 Responsible for Operation of three Fluid Bed Dryers Leading a team of 22 Manufacturing Operators Review of EBR for Tea Manufacturing. Update SOPs and Safety Procedures Review of Production Log books. Writing investigations for Quality issues. Process improvement using LEAN MFG TECHNIQUESFilling SupervisorHOSPIRA FormulationFebruary 2013 to August 2014Responsible for Formulation and Filling of Solution and Emulsion products.Leading a team of 9 Operators.Batch record reviews.Participating on Process Improvement Teams.Writing investigations for Quality issuesSERVICES Associate Aseptic Manufacturing/ Filling ManagerAAI PHARMANovember 2011 to February 2013Responsible for Component Prep, Formulation Inspection, Packaging, and Sterile Filling of Commercialas well as Clinical batches for outside clients.Supervise 9 Techs in all Departments.Responsible for schedule attainment which includes P&LWorking on Process and equipment improvements as well as SOP andBatch Record changes.MERCK INC, Aseptic Filling SupervisorWriting Quality Event investigations. May 2010 to November 2011Scheduled two fill lines and conducted training and SOP updatesConducted Training and implemented 5S activities.Responsible for validation of new procedures and changes.Led Kaizen team in the standardization of line clearances and cleaning.Production SupervisorConAgra FoodsJanuary 2008 to December 2009Responsible for 4 Automated Packaging lines and 6 Cutting linesSupervised 80 employeesGLAXOSMITHKLINE, Production Supervisor 2000-2008Set up three state of the art Assembly/Packaging lines in new MD PI facility.Involved in all Validation of Assembly/Packaging Lines and FATsConducted line training for entire shift of 40 operators and 4 shift leaders Coordinated the production of Advair on 4 Blend/Fill lines and 4 Assembly/Packaging line.Conducted training on 5s Activities for entire Advair Department.Performed Quality Auditing for ADVAIR Facility for 3 yearsGLAXOSMITHKLINE, Production Leader 1999 2000Initiated a program to increase production and efficiencies throughout the organization Maintained production equipment for installations in the Zebulon, North Carolina plant.Provided technical assistance and logistics problem solving for equipment.Oversaw HAZMAT disposal and consultingWrote SOP's and JSAs for Assembly Equipment.Trained as a QA Validation Technician responsible for Facilities and ProcessValidation start up.Production CoordinatorNOVO NORDISK PHARMACEUTICAL INDUSTRIES January 1996 to December 1999Recognized for outstanding performance and leadership skills in the production environmentAchieved senior leadership role to train incoming operatorsCompleted first cartridge stability batches under severe time constraintsAssisted with NNPII start up and process preparations for FDA Pre-ApprovalInspection forAuthored multiple SOPs and training formats for the companyAnalyzed protocols for quality/accuracy and assisted in the execution of validation processes forOperational Qualifications and Performance Qualifications for FDA certification of equipment and processes.Responsible for the successful scale up of 500 Lt. Insulin batches to 3000Lt. BatchPlasma Production and Inventory Control TechnicianBAYER PHARMACEUTICALSJanuary 1982 to December 1996Responsible for all aspects of Plasma ProductionOrdered all Chemicals and Filters used in the facilityManaged inventory control of all itemsMaintained inventory records viewed by the FDA and most aspects of theWarehouse operationsEducationAssociates Degree in OperationsJOHNSTON COMMUNITY COLLEGE - Bethesda, MDSkillsProcess ImprovementSix SigmaLean5SCGMPRoot Cause AnalysisCalibrationSAPLean Six SigmaQuality AuditsSenior LeadershipTeam ManagementLean ManufacturingQuality InspectionQuality ManagementPurchasingQuality AssuranceAuditingChange ManagementProduction ManagementProfit & LossMicrometerCalipersCustomer serviceFDA regulationsOSHATechnical writingCleanroomMaterials managementManagementManagementManufacturingCommunication skillsFood processingBasic math |
