Manager Of Regulatory Affairs Resumes in North Carolina
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1.
J Motola Location: Greenville, NC 27834 ... CUTIVE SUMMARY Core CompetenciesSele cted Achievement HighlightsDevelo ps intellectual capital in the form of automated and value-added quality testing and compliance program management.Devis es cost-efficient QA procedures, processes conforming to 21CFR 210, 211, 820 and 21 CFR Part 11, QA project management and quality best practice(s).Func tions as the expert contact for quality and compliance solutions featuring best-practice implementations for quality and regulatory compliance.Exten sive Corporate Quality expertise developing and assuring regulatory compliance best-practices as well as optimized quality assurance and quality control solutions.Delive rs management and guidance related ...
97 hits
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R Mcdonie Location: Wilson, NC 27893 ... 19-816-1614 Aug. 2007 to Dec. 4, 2007 (lay-off) ADVANCED / RESEARCH CHEMIST Research and development in an agro-chemical laboratory. Methods development and methods enhancement employing wet chemistries, e.g. liquid-liquid extraction, SPE, etc. and analytical chemistry via HPLC, GC, GC/MS, and HPLC-MS/MS. These methods were developed primarily for the analysis tobaccos and their related products, but these methods could also be modified for the chemical analyses other matrices. I also performed, e.g. writing SOPs and work order instructions, method validations, and quality control procedures and documentation. Laboratory resource for fellow chemists and lab technicians. Microbac Laboratories ...
95 hits
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R Botts Location: NEW Bern, NC 28560 ... t initiatives in varied manufacturing facilities, including multi-plant and start-up operations. Demonstrated success implementing quality improvement and Lean TPS process manufacturing concepts utilizing six sigma principles, value-added / TPS methods, process controls, and Kaizen events. Highly effective results implementing cost reduction, resource re-allocation programs for quality and profit maximization in high volume, ISO, QS, TS manufacturing environments. Successful P & L management. International experiences in China, Mexico, Italy, Turkey, Korea, France and Japan. • Quality Management • TPS / Lean Manufacturing • FMEA, APQP, PPAP • Six Sigma, 5-S • Value Stream Mapping ...
93 hits
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E Anderson Location: Greensboro, NC 27406 ... Objective: Full time employment Skills/ Experience: Qualified in Quality Assurance since 2000. Worked as a Good Manufacturer Policy and Procedures Coordinator for Oral Care in Dentifrice Making Module (Procter & Gamble). Conducted audits (Corporate, FDA, Daily Internal & Weekly Audits). Updated, wrote and trained employees on all GMP and Quality related standards and procedures. Responsible for maintaining and storing all records and documents. Assigned all training and tracked results. Responsible for signing off on all Skill Blocks and Training Qualifications for employees. Responsible for maintaining cleaning standards and holding teams accountable for results. Lead ...
91 hits
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G Struble Location: Raleigh, NC 27612 ... s responsibilities included Process Validation, Sr. Validation Engineer, Commissioning Facility Manager, Project Manager, Process Manager, Manager of Validation and QA and QC and Reviewing Manager, Documentation and Commissioning Manager. Extensive experience in reviewing quality protocols and supporting documents and commissioning and ETOP protocols including validation and maintenance of facility security systems, clean and dirty utilities, (HVAC systems, electrical systems, plumbing systems, Fire Alarm systems, Building automation systems, Automated control systems, waste systems, preventive maintenance SOPs, SMIs, CMMS, BAS, FMEA. Extensive experience with Process mapping, CAPA, VP, ...
89 hits
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J Moorman Location: Raleigh, NC 27613 ... I's) to measure and define employee success.FMEA Analysis CAPA Systems DesignExtensive IT Test Management for Testing Process Assessments UAT and Database and Functional Testing Integration Test, Test/Use Case Design, StoryboardsCMMI Levels 1, 2, 3 Malcolm Baldrige Quality Award for AT&TChange Management Implementation Release ManagementFACETS HP Quality Center (Test Director)Vendor Management Quality Mgmt/Test Plans, SOPs, RequirementsGAP Analysis of Processes/Proced ures Creation of Validation Master Plans21 CFR Part 11/Sarbanes Oxley LIMS, Systems and Lab Equipment, SAP ScriptsInternal Audit of CAPA Records, SOP's, OQ/PQ/IQ procedures and FDA ComplianceGAMP-4 , ICH, ...
87 hits
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W Crosby Location: Charlotte, NC 28273 ... tory agencies, I have been able to maintain environmental compliance, for multiple U.S. Postal facilities, across the states of North and South Carolina. I am currently seeking an environmental management position with responsibilities for maintaining environmental compliance and management system development for a single or multiple facility sites. Work Experience: Area Environmental Specialist United States Postal Service, Charlotte, North Carolina 10/1994 - Present. Accomplishes and maintains environmental compliance by providing technical support, direction and operational procedures in the areas of proper handling/disposa l of industrial wastewater, storm water, air quality issue ...
85 hits
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J Gagliardi Location: Franklinton, NC 27525 ... (920) 625-9921 JG1572@yahoo.com Career Summary: I am a seasoned, degreed, proactive, hands-on Quality Assurance/Proces s Engineering Professional with 25 years of global, multi-plant experience in military, automotive and commercial manufacturing environments. My process experience includes membrane switch manufacturing, metal fabrication, telecommunicatio ns, electronic contract manufacturing, electrical /electro-mechani cal assembly, high speed conductive/graph ic printing, printed circuit board fabrication, plastic injection molding and medical device manufacturing. I am seeking a seni ...
83 hits
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R Goodnight Location: Concord, NC 28025 ... ei der Electric / Square D - Charlotte, NC 2002-2008Square D / Integrated Power and Control Solutions, offers electrical distribution equipment and controls based upon customer specified engineering specifications with twenty-four hour after shipment customer technical support.Site Quality Manager &Customer Technical Support and Warranty ManagerDeveloped , implemented and maintained the site Quality Management System (QMS) and Product Warranty Program. Supported implementation of new product technologies, and procedures for quality and manufacturing requirements. Managed gathering and analyzing manufacturing and quality data to improve processes and product quality. Selected, developed a ...
81 hits
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T Carter Location: Concord, NC 28027 ... renas. Specific focus has been in quality engineering, procurement engineering, supplier quality assurance, and program management. Demonstrated strength in leadership, team building, customer interface and change management. Accomplishments include; ISO 9001: 2000, TS16949 and AS9100 implementation, secured FAA/JAA approval for Part 145 Repair Station, achieved and sustained NADCAP approval for nondestructive testing, obtained several designated source inspection statuses from major customers, secured several CASE approvals and implementation of Supplier Performance Rating system. EMPLOYMENT BALDOR ELECTRIC (AC and DC Industrial Motors), Fort Mill, SC 10/03 – Present Quality Assurance Mana ...
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