Writing Exceptional Audit Reports TUT02

Mary Chris Easterly is an ASQ Certified Quality Auditor (CQA) since 1998 and Certified Manager of Quality/Organizational Excellence since 2000.  She is a Divisional GMP Auditor at Merck.  She is currently responsible for performing audits of Merck sites, contractors, and supplier audits.  Over the last 25 years working for pharmaceutical and medical device companies, she has managed and executed a variety of Quality Assurance and engineering functions, including internal audit and supplier quality programs.  She has been responsible for coordinating regulatory inspections, client audits, and corporate audits.

Mary Chris has presented the Writing Exceptional Audit Reports pre-conference tutorial at ASQ Audit Division Conferences.  She has presented sessions on various quality and auditing topics at section ASQ conferences and an Institute for Supply Management meeting, at Institute of Validation Technology seminars, and at the International Pharmaceutical Academy.

Mary Chris has a B.S. in Industrial Engineering and Operations Research from Virginia Polytechnic Institute and State University, and a M.S. in Quality Assurance from California State University at Dominguez Hills.  She is a senior member of ASQ and past Chair of the Raleigh section.  Mary Chris has taught ASQ CQA exam preparation courses.  She participated in the ASQ Certified Pharmaceutical GMP Professional exam development and handbook writing processes, and in an ASQ focus group to investigate the possibility of a second tier of auditor certification.