Thomas Clements

Thomas Clements Email and Phone Number

Interested in full time employment
Thomas Clements's Location
Durham, North Carolina, United States, United States
Thomas Clements's Contact Details
About Thomas Clements

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.

Thomas Clements's Current Company Details

Interested in full time employment
Thomas Clements Work Experience Details
  • Walmart
    Guest Services Associate
    Walmart Jul 2012 - Jan 2016
    Bentonville, Arkansas, Us
    Grocery Claims Associate Responsible for recording and destroying departmental returned, out of date, damaged or recalled merchandise.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.
  • Inc Research
    Manager, Life Cycle Management And Validation
    Inc Research Jan 2009 - Mar 2010
    Raleigh, North Carolina, Us
    Oversees 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.
  • Genzyme Corporation
    Senior It Compliance/Validation Engineer
    Genzyme Corporation Oct 2006 - Dec 2008
    Responsible 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.
  • Talecris Biotherapeutics
    Computer Systems Validation Specialist
    Talecris Biotherapeutics Dec 2005 - Jul 2006
    Responsible 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.
  • Glaxo Smith Kline (Gsk
    Qa Tester/ Validation Analyst
    Glaxo Smith Kline (Gsk Jun 2005 - Dec 2005
    Performing 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.
  • Steris Laboratories
    Computer Validation Engineer
    Steris Laboratories May 2004 - Oct 2004
    Performed 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.
  • Schering-Plough
    Computer Validation Engineer
    Schering-Plough Mar 2003 - Dec 2003
    Worked 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.
  • Eli Lilly
    Senior Computer Validation Engineer
    Eli Lilly Mar 2002 - Mar 2003
    Indianapolis, Indiana, Us
    Validated 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.
  • Oxford International
    Validation Engineer
    Oxford International 2002 - 2003
    Beverly, Massachusetts, Us
  • Snbl Usa Ltd
    Computer Validation Specialist
    Snbl Usa Ltd May 2001 - Jan 2002
    Kagoshima, Kagoshima, Jp
    Developed 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.
  • Questcon Technologies
    Test Analyst
    Questcon Technologies Oct 2000 - Feb 2001
    Peer 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.
  • Graydon Corporation
    Validation Specialist
    Graydon Corporation Jul 2000 - Oct 2000
    Preparation 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.
  • Kmi-Parexel
    Validation Specialist
    Kmi-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.
  • Maxim Group
    Y2K Mvs Test Analyst
    Maxim Group Apr 1999 - Jul 1999
    Performed 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.
  • Maxim Group
    Y2K Test Analyst
    Maxim Group Jul 1998 - Feb 1999
    Performed 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.
  • Summit Medical
    Quality Assurance Test Manager
    Summit Medical Apr 1998 - Jun 1998
    Developed, 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.
  • Maxim Group
    System Application Tester
    Maxim Group Oct 1997 - Apr 1998
    Automated 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.
  • Labcorp,
    Senior Programmer Analyst/Quality Assurance Engineer
    Labcorp, Mar 1997 - Oct 1997
    Quality Assurance testing on CICS, DB2, and COBOL source code using JCL, Fileaid, Strobe and Xpediter in an IBM MVS environment
  • Sai Software
    Computer Validation Engineer
    Sai Software Sep 1996 - Nov 1996
    Validated 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.
  • Kelly Technical,
    Quality Assurance Test Engineer
    Kelly Technical, Mar 1996 - Sep 1996
    Performed 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.
  • Sei
    Quality Assurance Tester
    Sei Oct 1995 - Feb 1996
    Performed 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.
  • Manpower  Technical,
    Test Engineer
    Manpower Technical, Mar 1995 - Oct 1995
    Integration, 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
  • Resource Support Associates
    Data Processing Consultant
    Resource Support Associates Jun 1994 - Feb 1995
    Coordinated 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.
  • Computer Professional Inc
    National Language Support Consultant
    Computer Professional Inc Sep 1993 - Mar 1994
    Responsible for NLS maintaining, enhancing, and supporting supermarket applications executing on IBM OS/2, 4680 and 4690 Point of Sales Store Systems.
  • Computer Task Group
    Systems Engineering Consultant
    Computer Task Group Mar 1992 - Sep 1993
    Performed 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.
  • Cdi Corporation
    Icon Disk Manager
    Cdi Corporation Jun 1991 - Feb 1992
    Processed, 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.
  • Mgv-America
    Test Engineer
    Mgv-America Mar 1991 - Jun 1991
    Integration 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.
  • Data General Corporation
    Programmer Analyst
    Data General Corporation Jan 1990 - Feb 1991
    Developed, 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.
  • Tenneco Oil Company
    Store Manager
    Tenneco Oil Company Mar 1984 - Mar 1987
    Managed Truck Stops, Supermarkets and Convenience Stores. Employed in the state of Florida.
  • Quik Check Food Stores
    Assistant Manager
    Quik Check Food Stores Apr 1982 - Mar 1984
    Ran Food Stores in the state of New Jersey. Performed all the duties of operating a store.
  • The Great Atlantic & Pacific Tea Company (A&P)
    Clerk, Cashier, Price Marker
    The Great Atlantic & Pacific Tea Company (A&P) Aug 1970 - Feb 1982
    Performed all function within a supermarket.

Thomas Clements Skills

Quality Assurance Software Documentation 21 Cfr Part 11 Lifesciences Validation Document Management Fda Sdlc Computer System Validation Testing Unix Manufacturing Gmp Databases Oracle Quality Auditing V&v Capa Sop Change Control Integration Lims Gxp

Thomas Clements Education Details

  • Pennwest California
    Pennwest California
    Environmental Science
  • Devry University
    Devry University
    Computer Information Systems
  • Millersville University Of Pennsylvania
    Millersville University Of Pennsylvania
    Transferred
  • Northampton Community College
    Northampton Community College
    Environmental Studies
  • Devry University
    Devry University
    Computer 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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