Industry Consultant

SUMMARY

QA specialist with over 29 years of experience in computer validation, development of processes, and auditing for regulatory compliance. 

Objective

QA specialist with over 29 years of experience in computer validation, development of processes, and auditing for regulatory compliance. 

Experience

Consulting Firm  

01/2019-Present

Industry Consultant

  • Consultant for all Quality Assurance services, specializing in CSV, process improvement and hosted service/vendor assessments. 

Charles River Laboratories, Mattawan, MI: 04/2018 – 12/2018

Senior QA Specialist

  • IT (Facility) inspections and Computer System Validation audits.

MPI Research, Mattawan, MI: 05/2004 – 04/2018

QA Compliance Professional, 05/2006-04/2018

  • Audited laboratory processes and reviewed protocols, study data and reports for GLP compliance.
  • Conducted periodic reviews of validated systems to confirm continued compliance.
  • Designed a Software Quality Testing and Development review program for Quality Assurance that enhanced communication and compliance. 

Senior Compliance Auditor, 10/2005-05/2006

  • Developed a validation standardized process with Information Technology groups, Laboratory users, Quality Assurance, Report Preparation, and Technical Writers for GLP data collection systems.
  • Collaborated with the Metrology Group to establish and formalize an IQ/OQ/PQ process that exceeded regulatory guidelines.  

QA Auditor II, 05/2004-10/2005

  • Audited laboratory processes and reviewed protocols, study data and reports for GLP compliance.
  • Specialized in Cardiovascular Telemetry data review.
  • Conducted periodic reviews of validated systems to confirm continued compliance.

IRDC, Mattawan, MI: 02/1990-11/1995

    • Audited laboratory processes and reviewed protocols, study data and reports for GLP compliance.
  • Specialized in Metabolism data review.

Education

Western Michigan University, Bachelor of Arts, 06/1980

  • Majored in Geography, minored in German and Music
  • Geography Honors College member 

Professional Activities
  • Poster presentation titled “Cloud Computing: Greener Pastures?” at SQA Annual Meeting, Tampa, FL- 04/2016
  • Poster presentation titled “Computer Validation II- Evolution of a ‘Standardized Process’” (Authors: Jo Anne Wisser, John Zenk, Andrea Hurst) at 20th Anniversary SQA Meeting, Reno, NV- 04/2004
  • Poster presentation titled “Computer Validation- The Design and Implementation of a ‘Standardized Process’” at SQA Annual Meeting, Washington, D.C.- 10/2003
  • Poster presentation titled “Computer Validation- The Design and Implementation of a ‘Standardized Process’” (People’s Choice Award, First Place for Best Poster) at SQA Spring Meeting- 07/2003
  • Presenter, “Maintaining GLP Compliance in a Contract Research Organization” at Strategic GLP Compliance Summit, Sponsor-CPT (of IQPC- International Quality and Productivity Center)- 04/2003
  • Contributing author of presentation for Dr. Richard Briscoe, “User vs. Vendor… Case Study: QA and the CRO Telemetry Service Provider” at SQA Annual Meeting, Albuquerque, NM- 10/2002

Certifications, Memberships, and Awards
  • Member of Society of Quality Assurance (SQA) 1994-Present
  • Registered Quality Assurance Professional- Good Laboratory Practice (RQAP-GLP): 2001-2016 (Pending recertification: 2019-2022)
  • Member of American Society of Quality (ASQ) 2006-2007
  • Step UP Awards (Peer Driven)- Teamwork (3) 2015, 2016, 2017; Efficiency (1) and Innovation (1) 2017

 

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