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Experienced Computer Systems Validation Specialist with expert knowledge of 21 CFR Part 11 compliance and cGMP. Proven leader with a team oriented focus in guilding successful validation projects focused on Biotechnology and Pharmaceutical manufacturing. Strong interpersonal skills, effective communications with attention to detail. Well versed in Process Analytics, IQ/OQ/PQ authoring, execution and Deviation resolution.
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Guest Services AssociateWalmart Jul 2012 - Jan 2016Bentonville, Arkansas, UsGrocery Claims Associate Responsible for recording and destroying departmental returned, out of date, damaged or recalled merchandise. Performed administration tasks using a hand held computer devise and/or a PDA. Direct Sales Distribution Associate (DSN). Responsible for recording and checking in all merchandise that arrives for sale at the store.. Consumable Sales Associate Responsible for stocking grocery, HBA, pets, paper, candy, and chemicals. Performed minor administration tasks using a hand held computer devise and/or a PDA. -
Manager, Life Cycle Management And ValidationInc Research Jan 2009 - Mar 2010Raleigh, North Carolina, UsOversees life cycle management, testing, validation and documentation of systems supporting INC Research. Ensures test plans, summary reports and other computer validation documents are developed and maintained in accordance with Corporate Standard Operating Procedures. -
Senior It Compliance/Validation EngineerGenzyme Corporation Oct 2006 - Dec 2008Responsible for coordinating validation efforts for projects. Author validation plans and protocols to ensure compliance with regulatory standards. Develop standards and guidelines related to computer systems validation and system implementation methodology. Promote awareness within IT of validation requirements and of good IT practices. Uses risk analysis to develop validation approaches to computer applications and infrastructure.
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Computer Systems Validation SpecialistTalecris Biotherapeutics Dec 2005 - Jul 2006Responsible for computer systems validation of a large dynamic conversion project. Servers and applications were transfer from Bayer Data Center in Pittsburgh and West Haven to Talecris Data Center in Clayton. Duties included writing validation documents that included Traceability Matrix, Test Plans, Validation Plans, IOs, OQs, Change Control, Risk Assessments and Summary Reports.
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Qa Tester/ Validation AnalystGlaxo Smith Kline (Gsk Jun 2005 - Dec 2005Performing Quality Assurance testing and validation on a web-based GMP compliant shipment and clinical address management system developed by Glaxo Smith Kline (GSK ) Pre Clinical IT department. The systems provide an electronic shipment which processes and tracks orders from distribution centers to destination sites.
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Computer Validation EngineerSteris Laboratories May 2004 - Oct 2004Performed remediation and validation of legacy and new computer systems. Duties included GxP assessments, GAP Assessments, writing Validation Plans, User Requirements, Functional Specifications, IQs, OQs, PQs and Summary Reports.
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Computer Validation EngineerSchering-Plough Mar 2003 - Dec 2003Worked on remediation of Legacy Computer Systems at Schering-Plough. This involved both computer validation and remediation efforts in order to bring these systems into compliance with both 21CFR Part 11 regulations and cGMP standards. The process involved investigative efforts and creation of relevant documentation i.e. GAP Analysis, Remediation Plans, As-Is documentation, Test Scripts (IQ OQ), SOPs and Validation Summary Reports. The systems included IBM mainframe applications i.e. Production Order System, written in Cobol and DB2 and LAN applications i.e. Electronic Managements Systems.
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Senior Computer Validation EngineerEli Lilly Mar 2002 - Mar 2003Indianapolis, Indiana, UsValidated pharmaceutical computer systems, manufacturing facilities and process equipment at Eli Lilly following GAMP, FDA, GxP, 21 CFR Part 11 regulations. Duties included writing and executing computer validation test cases and protocols, performing assessments of physical and logical security requirements, vendor audits, generating documentation, developed Standard Operating Procedures, providing technical support and performing analysis of current systems. Performed day-to-day management of assigned projects, project scheduling, tracking, and resource management, client interface and supply recommendations for corrective actions. -
Validation EngineerOxford International 2002 - 2003Beverly, Massachusetts, Us -
Computer Validation SpecialistSnbl Usa Ltd May 2001 - Jan 2002Kagoshima, Kagoshima, JpDeveloped and executed Installation Qualification, Operation Qualification, and Performance Qualification plans for software used in an FDA regulated environment. Performed parallel testing of an Electronic Data Management System used for mission-critical data collection. Performed vendor pre-selection audits for software purchasing decisions. Wrote validation plans, test scripts, test cases, reports and project documents. -
Test AnalystQuestcon Technologies Oct 2000 - Feb 2001Peer review of test cases written for IBM MVS COBOL/DB2 and UNIX environments at AT&T. Executed test cases for the new application that was rewritten in Microfocus COBOL, using CoolGen screen generator and Oracle 8.0 databases operating on a SUN UNIX and NCR UNIX environment. Developed and validated test cases, recorded and resolved defects and coordinated with test lead to insure that testing methodologies were followed.
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Validation SpecialistGraydon Corporation Jul 2000 - Oct 2000Preparation and review of Standard Operating Procedures (SOPs) in the Glaxo-Wellcome Corporate Compliance and Validation Department, Zebulon, North Carolina. SOPs were used by Laboratory Systems (LIMS), Information Systems and Automation Systems.
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Validation SpecialistKmi-Parexel Sep 1999 - Sep 2000 Validation of pharmaceutical client computerized systems, manufacturing facilities, and process equipment; preparation and/or review of requirements, specifications and qualification protocols; preparation and review of Standard Operating Procedures (SOPs); on-site protocol execution; data analysis; and preparation and review of final reports. Performed day-to-day management of assigned projects, project scheduling, tracking, and resource management, client interface and supply recommendations for corrective actions.
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Y2K Mvs Test AnalystMaxim Group Apr 1999 - Jul 1999Performed Y2K testing and analysis of COBOL applications using SuperCe and Fileaid in an IBM MVS environment at Duke University. PCs were used to emulate to the mainframe using IBM eNetwork Personal Communications running Window NT over a Novell Network.
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Y2K Test AnalystMaxim Group Jul 1998 - Feb 1999Performed analysis, assessment and testing of an MCI Fiber Optical Locator Protection application on Visual Basic 5.0, Oracle 8.0, and Crystal Reports. Setup test environment, developed test plans, test cases, and test reports.
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Quality Assurance Test ManagerSummit Medical Apr 1998 - Jun 1998Developed, implemented and coordinated product assurance programs to prevent or eliminate product defects using Microsoft Solutions Framework. Designed testing environment, developed test plans, monitored test execution and documented results. Oversaw issue tracking and resolution. Evaluated software products for future use that included WinRunner, SILK and TestBytes.
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System Application TesterMaxim Group Oct 1997 - Apr 1998Automated system application testing using QA Partner at IBM Global Services/ Qualex. Converted an IBM Series One Event Driven Executive System application to an IBM Pentium Pro Client Server Windows NT processing system. The application was written in C++ and Powerbulder, TCP/IP protocol within plant and across Advantis WAN protocol network.
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Senior Programmer Analyst/Quality Assurance EngineerLabcorp, Mar 1997 - Oct 1997Quality Assurance testing on CICS, DB2, and COBOL source code using JCL, Fileaid, Strobe and Xpediter in an IBM MVS environment
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Computer Validation EngineerSai Software Sep 1996 - Nov 1996Validated pharmaceutical information and business computer systems at Glaxo-Welcome following FDA cGMP regulations. Duties included writing and executing computer validation test cases and protocols, generating documentation, providing technical support and performing analysis of current systems.
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Quality Assurance Test EngineerKelly Technical, Mar 1996 - Sep 1996Performed testing at Imonics Corporation on imaging and workflow healthcare automation software. Developed and validated test plans, recorded and solved defects and coordinated with developers to insure Imonics methodologies were followed. Regression tested applications using QA Partner.
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Quality Assurance TesterSei Oct 1995 - Feb 1996Performed testing on IBM Personnel Communications emulating software at IBM in RTP, North Carolina. Applications were tested on an AS/400, MVS and a client server network. Developed and validated test plans, recorded bugs into the CMVC bug-tracking database.
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Test EngineerManpower Technical, Mar 1995 - Oct 1995Integration, function, product and regression testing of software preloads on IBM 300 and 700 series PCs including Pentium models. Software included PC DOS 6.3/7.0. Windows 3.x 95, OS/2 Warp v3.0 and CoSessions
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Data Processing ConsultantResource Support Associates Jun 1994 - Feb 1995Coordinated operations and provided support to computer applications in VM/CMS and PC environments. Served as Data Processing technical liaison between the Clerk of the Legislature and the Reviser of Statutes offices and Nebraska State Government state agencies.
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National Language Support ConsultantComputer Professional Inc Sep 1993 - Mar 1994Responsible for NLS maintaining, enhancing, and supporting supermarket applications executing on IBM OS/2, 4680 and 4690 Point of Sales Store Systems.
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Systems Engineering ConsultantComputer Task Group Mar 1992 - Sep 1993Performed Quality Assurance testing on IBM Cross Systems Product (CSPv4.1). Defined, tested, generated, and executed applications on an IBM AS/400 system. COBOL applications were generated for mainframe environments including CICS/MVS and TSO using DB2 databases. Processed "test to production" requests for the programming staff at General Electric Capital Mortgage Insurance Company. Screened, implemented, documented, and tracked the movement of CICS and COBOL source code using PANVALET utilities, IDCAMS, and TSO/ISPF in an IBM 3090 MVS environment.
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Icon Disk ManagerCdi Corporation Jun 1991 - Feb 1992Processed, tracked, and maintained ICON data information for IBM. Managed an ICON database and performed editing updates to the ICON Reference Book using Bookmaster and ICON Editor.
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Test EngineerMgv-America Mar 1991 - Jun 1991Integration and system test prime on Remote Operator software for the IBM 4684 POS system, to verify performance to the specifications. Tested the PC, PS/2 modules in an ASYNC, SDLC Direct, SNA/Host, and LAN environments.
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Programmer AnalystData General Corporation Jan 1990 - Feb 1991Developed, maintained, enhanced and supported business and manufacturing applications. Supported multiple Warehouse Inventory Systems consisting of over a half million lines of COBOL code (with embedded SQL) that included real-time, multitasking, on-line and batch processing environments.
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Store ManagerTenneco Oil Company Mar 1984 - Mar 1987Managed Truck Stops, Supermarkets and Convenience Stores. Employed in the state of Florida.
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Assistant ManagerQuik Check Food Stores Apr 1982 - Mar 1984Ran Food Stores in the state of New Jersey. Performed all the duties of operating a store.
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Clerk, Cashier, Price MarkerThe Great Atlantic & Pacific Tea Company (A&P) Aug 1970 - Feb 1982Performed all function within a supermarket.
Thomas Clements Skills
Thomas Clements Education Details
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Pennwest CaliforniaEnvironmental Science -
Devry UniversityComputer Information Systems -
Millersville University Of PennsylvaniaTransferred -
Northampton Community CollegeEnvironmental Studies -
Devry UniversityComputer Information Systems
Frequently Asked Questions about Thomas Clements
What is Thomas Clements's role at the current company?
Thomas Clements's current role is Interested in full time employment.
What is Thomas Clements's email address?
Thomas Clements's email address is tf****@****ail.com
What schools did Thomas Clements attend?
Thomas Clements attended Pennwest California, Devry University, Millersville University Of Pennsylvania, Northampton Community College, Devry University.
What are some of Thomas Clements's interests?
Thomas Clements has interest in Social Services, Economic Empowerment, Politics, Education, Environment, Arts And Culture, Science And Technology, Bowling, Disaster And Humanitarian Relief, Walking.
What skills is Thomas Clements known for?
Thomas Clements has skills like Quality Assurance, Software Documentation, 21 Cfr Part 11, Lifesciences, Validation, Document Management, Fda, Sdlc, Computer System Validation, Testing, Unix, Manufacturing.
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