Gretchen McAuliffe is one of the co-founders of Labtopia. As a Principal, Gretchen oversees operations for Labtopia Staffing and is Senior Consultant for Labtopia Solutions, Labtopia Training and Labtopia Informatix. Gretchen specializes in providing quality assurance support to ISO and GxP manufacturers, laboratories, and distributors. As a QA professional, she is an expert in developing integrated systems for regulated industries. She has extensive experience in quality management systems, technical writing, business process mapping, database requirements and implementation, document control, and laboratory compliance. During her career, she has managed and conducted domestic and international audits of manufacturers, distributors and laboratories.
Gretchen has a B.S. in Biology from the University of Houston and a M.S. in Biological Sciences from the University of Houston-Clear Lake. She is an American Society for Quality (ASQ) Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), Certified HACCP Auditor (CHA). She is also one of the first GMP professionals in the world to be certified to ASQ Certified Pharmaceutical GMP Professionals (CPGP) criteria. She is also a certified ISO 9001:2000 lead auditor. She has received training in Good Laboratory Practices, Good Manufacturing Practices and International Pharmaceutical Excipient Council Good Manufacturing Practices for Excipients. In addition, Gretchen is a trained Administrator for ThermoFisher Scientific’s SampleManager LIMS.
Gretchen has provided support to companies who must comply with good manufacturing practices (GMPs), good laboratory practices (GLPs), good clinical practices (GCPs), ISO 9001:2008, ISO 17025:2005, ISO 22000 and Safe Quality Foods (SQF).
When she finds time to relax, Gretchen enjoys spending time with her husband Shannon McAuliffe and their two daughters, Caitlin & Ciara. She enjoys traveling, a good book and a dinner with family and friends.