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Click here or scroll down to respond to this candidateCandidate's Name , JR.Street Address Brookside DriveBristol, CT Street Address
Cell PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLEProfessionalObjective: SENIOR QUALITY POSITION IN QUALITY ASSURANCE DISCIPLINEEMPLOYMENT HISTORY5/9/22 to ALLERQUEST, LLC.Present PLAINVILLE, CTPOSITION: COMPLIANCE LEADPlan and Lead Supplier Quality ProgramoDevelop annual audit scheduleoComplete supplier audits according to planoComplete supplier risk assessmentoComplete supplier performance monitoringDeveloped supplier scorecardoInitiate, review and approve Quality Technical Agreements with key suppliersoReview and assess supplier change notificationsInitiate internal change requests if requiredPlan and Lead Internal Audit ProgramoDevelop annual internal audit scheduleoPerform internal audits and report findings, track corrective actions for Quality System elementsoTrain associates to conduct internal auditsPlan and Lead Management Review ProgramoCoordinate compilation of Management Review dataoDevelop supplier data and internal audit data for inclusion in Management ReviewoLead presentation to Company President and AllerQuest Management staffGeneral Compliance Support (as needed basis)oReview Corrective and Preventative Actions specifically for impact on vendors as well as for overall compliance with internal policiesoReview of protocols and reports10/05 to JANSSEN SUPPLY CHAIN (JSC)8/17 HORSHAM, PA(Retired)POSITION: MANAGER, EXTERNAL SUPPLY INTEGRATION QUALITY (ESIQ-NA)Plan and Lead Supplier Audits for API, Excipient, Packaging, Device, and Sterilization suppliersoInternational and domestic travel approximately 50-60% of time.oPlan and conduct audits of Suppliers of Medical Devices and Device ComponentsoAuthored audit agendae and audit reportsoLead SQ activities related to new Combination Products or DevicesoDevice SME for ESIQ- SQ related to Device and Device Component suppliers and manufacturers.oProvide SQ representation on new product development for combination products.Direct and Manage the Development, Partnership, and Deployment of 3rd Party Auditing Service for JSC.Led the initiation of deployment of the innovative process of SQE2 within JSC.ESIQ Supplier Account Owner for suppliers of excipients, medical devices, packaging components, external manufacturers, and other component suppliers worldwideAccount Owner for the Vacaville (ALZA) facility.oDeveloped Quality KPIs, and presented results at Management ReviewsLeads SQ activities on new products related to combination products in areas of stem cell development, and other drug/device and bio/device combination products.Direct Supplier Quality activities related to External Manufacturers product quality issues, specifically in the areas of Combination Products.Received several Johnson & Johnson awards for key participation in audits, and collaboration between sectors (Pharma/Consumer/Medical Devices).2/05 to ETHICON, INC.10/05 SOMERVILLE, NJPOSITION: SENIOR PROJECT MANAGER- COMPLIANCEPlan and conduct audits of chemical, component, and external manufacturing suppliers worldwide. Author audit agendae and audit reportsSupport plant QA as requiredInitiated trials and primary site user of Pilgrim supplier audit database8/03 to MEDEX, INC. (acquired from Ethicon Endo-Surgery)2/05 SOUTHINGTON, CTPOSITION: CORPORATE COMPLIANCE MANAGERConducted internal audits of all Medex facilities worldwideConducted critical supplier audits for all Medex facilitiesAuthored all audit agendae and audit reportsDeveloped corporate internal audit and supplier audit procedures for use at all North America facilitiesServed as Interim Quality System Manager for the Monterrey MX facility from 9/03 to 9/04Led various integration teams following acquisition by MedexLed team for FDA facility inspections of Monterrey Mexico and Southington plants resulting in zero 483 items and zero recommendationsLed audit teams for Southington and Monterrey sites ISO audits resulting in zero nonconformances11/97 to ETHICON ENDO-SURGERY7/03 SOUTHINGTON, CTPOSITION: MANAGER, COMPLIANCE and SUPPLIER QUALITYDeveloped, prepared, and presented facility quality metrics for Management ReviewLead Quality Starpoint Team (Quality Council)Established and managed multi-site CAPA systemAuthored applicable procedures and Work InstructionsProvided on-site QA/Compliance support for Monterrey, MX facility (35-50% of time spent in Monterrey MX)Authored SOPs, Work Instructions, and Process Controls for key Quality System elementsProvided Compliance training and coaching for CT and Monterrey sitesManaged supplier and internal audit programsManaged facility Management Action Plan to assure regulatory compliance. Prepared metrics and reported in Management ReviewManaged environmental monitoring, complaints, raw material inspection, and sterilization issues for facility in order to meet and exceed regulatory requirementsReviewed SOPs, Work Instructions, Inspection Methods, Process Controls and revised as requiredLead multiple acquisition transition teams, including Supplier Quality, Sterilization, and Compliance. Conducted gap analysis of related procedures, and revised procedures as requiredLead multiple facilities in ISO/EN/CMDCAS assessmentsSuccessfully managed assessment to enhance ISO certification to include Design Control. Authored Design Control SOPs and Work InstructionsLed benchmarking of Management Review, CAPA, and Compliance Reporting with multiple companiesInitiated future state compliance assessments for CT and Monterrey sitesNegotiated pricing for outside laboratory tests resulting in annual cost savings of $150k50-75% travelPREVIOUSPOSITION: MANAGER, SUPPLIER/PRODUCT QUALITYManaged raw material inspection, calibration, metrology, in-process quality, and post-sterile inspectionMember of Signature of Quality Supplier Management Team, developed multi-site Supplier Quality ProcessImplemented FMEAs and Corrective Actions with key suppliers resulting in 80% reduction of non-conformancesCompleted Johnson and Johnson Leadership DevelopmentCompleted Black Belt (Six Sigma) Training and Supplier Certification ProjectAuthored Supplier Certification SOPManaged 10 direct reports6/93 to JOHNSON & JOHNSON PROFESSIONAL, INC.11/97 STAMFORD, CT (formerly Joint Medical Products)POSITION: MANAGER, QUALITY SYSTEMSManaged all QA/QC functions for Stamford facilityManaged facility GMP program to assure compliance with FDA and ISO requirementsManaged sterilization validation programsAuthored Process and Product Validation Protocols (IQ, OQ, PQ) and Validation Summary ReportsDeveloped and implemented supplier and operator certification programs resulting in indirect labor cost reductionsResponsible for daily regulatory compliance of facilityJJPI Award of Excellence for directing facility ISO certification effortsDeveloped, maintained, and monitored department budgetManaged 8 direct reports, 21 total reportsPREVIOUS DIRECTOR OF QA/RA (with Joint Medical Products)POSITIONS: MANAGER OF QUALITY ASSURANCEManaged all QA/QC/Regulatory compliance activitiesManaged supplier audit program to assure quality of incoming components. Authored audit agendae and audit reportsManaged complaint reporting process in accordance with FDA requirementsReviewed 510(k)s prior to FDA submission12/83 to DAVIS & GECK, DANBURY, CT5/93 POSITION: MANAGER- GMP & VALIDATIONValidated sterilization and manufacturing processes. Authored Validation protocols and summary reportsAudited facility and suppliers to assure GMP complianceDeveloped and maintained GMP training programManaged plant document systems (SOP/DMR/ MCN)Coordinated plant customer dissatisfaction programPREVIOUSPOSITION: PRODUCTION MANAGERManaged seven departments, including incentive-paid and wage employees, and a custom order departmentDirected 6 supervisors, 1 manufacturing engineer, 1 qualityengineer, with overall responsibility for 140 employeesHad total accountability for departments quality,productivity, and financial performanceDeveloped and monitored budget of $16MMCompleted variance analysis as requiredPRIORPOSITIONS: MANUFACTURING ENGINEERPRODUCTION SUPERVISOR3/79 to MK LABORATORIES, INC., FAIRFIELD, CT12/83 POSITION: PRODUCTION SUPERVISORSupervised 40 hourly employees in pharmaceuticalmanufacturing plantSupervised packaging of solid and liquid dosage formsSupervised tablet manufacturing and capsule filling operations12/76 to ANALABS, INC., NORTH HAVEN, CT3/79 POSITION: CHEMISTSynthesis of analytical chemical standardsSynthesis of stationary phases for gas chromatographsPromoted several times to chemist positionEDUCATIONB.S. Biology, Sacred Heart UniversityPost-grad studies Health Care Policy and ManagementVarious training courses including Software Validation, Supplier AuditingASQ CQA (Certified Quality Auditor- cert. 27443)ASQ CQM (Certified Quality Manager- cert. 7995)ASQ Senior MemberSOFTWAREMS Office Suite (Word, Excel, Powerpoint)TrackwiseComplianceWirePilgrimMS Project (limited)Minitab |
