066

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 20^th 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