Experience

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  Sequence Inc. - Quality and Compliance Services

  • United States

  • Principal Consultant

    • Jul 2016 - May 2024
    • United States

    Principal Consultant to Pharmaceutical, Life Science, and Cosmetic client companies for Computer System Validation and 21 CFR Part 11 compliance. Performed quality assessments of IT business processes, Standard Operating Procedures (SOPs), and historical documentation. Provided assessment reports...

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  Veredus

  • Raleigh-Durham, North Carolina Area

  • Quality Assurance Team Lead

    • Aug 2015 - Jun 2016
    • Raleigh-Durham, North Carolina Area

    Interacted and influenced the Genworth Financial, U.S. Mortgage Insurance (USMI) IT senior leadership in strategy development and process design for application software quality assurance testing. Assisted in the definition and implementation of the processes resulting in improved software qualit...

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  Opus Inspection

  • Tucson, Arizona

  • Manager of Quality Assurance and Business Analysis

    • Feb 2014 - Apr 2015
    • Tucson, Arizona

    Developed and implemented quality assurance and business analysis standards and processes applicable to all Opus Inspection software products delivered by the engineering department. Ensured engineering department compliance to minimum quality assurance testing and documentation standards as well...

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  Randstad Technologies US

  • Raleigh, North Carolina

  • Quality Engineer

    • Sep 2013 - Jan 2014
    • Raleigh, North Carolina

    Tested multi-tier vehicle inspection system to support North Carolina state vehicle inspection program and DMV law enforcement. Created and executed automated test scripts using Selenium IDE. Reported defects and prepared test results reports. Reverse-engineered baseline test requirements from sp...

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  Quintiles

  • Durham, NC

  • Systems Validation and Test Lead

    • 2006 - 2013
    • Durham, NC

    Provided leadership with software quality control and computer system validation activities including: methodology; preparation; execution; and remediation. Serves as consultant to computer system users, developers and other groups in support of establishing and meeting quality objectives.Prepare...

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  Compuware

  • Durham, NC

  • Business Analyst / Test Analyst

    • May 2002 - Dec 2006
    • Durham, NC

    Industry: Automotive Manufacturing - Tested in-house developed manufacturing quality traceability system. Created automated test scripts using TestPartner. Reported defects in TrackRecord. Prepared test results reports. Reverse-engineered baseline business requirements in Reconcile from design an...

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  PharmaSys, Inc.

  • United States

  • Computer Validation Specialist

    • Aug 2002 - May 2003
    • United States

    Computer validation consultant to global pharmaceutical companies. Responsible for validation of entire SDLC including requirements, design, test/validation plans (IQ, OQ and PQ), etc. Audited computer systems and computer validation documentation for cGMP compliance, including 21 CFR Part 11. Pr...

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  CompuVal, Inc.

  • North Carolina

  • Computer Validation Specialist

    • Sep 2001 - Jun 2002
    • North Carolina

    Independent computer validation consultant to global pharmaceutical companies. Prepared, executed and reviewed IQ, OQ and PQ Tests. Prepared validation protocols and test plans for internally developed and COTS applications that support Manufacturing and Quality Assurance following cGMP procedure...

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  Various Staffing Agencies

  • Raleigh, NC

  • Project Manager / Business Analyst

    • Apr 1999 - Jan 2001
    • Raleigh, NC

    Directed Web development team in creation of Vignette website for media industry business. Directed Internet application development and maintenance for banking industry clients. Tracked progress of project deliverables using MS Project. Prepared periodic financial reports and project plans for c...

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  Bristol-Myers Squibb

  • Morrisville, NC

  • Data Analyst

    • Aug 1983 - Feb 1999
    • Morrisville, NC

    Technical Project Manager/Data Analyst & Modeler/Quality Engineer (5 years) - Analyzed business processes, customer and user needs, and business opportunities in developing requirements of a Laboratory Information Management System (LIMS). Prepared Request for Proposal, solicited and evaluate...