Gordon Ely LexaMed

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Gordon Ely LexaMed Senior Project Manager

Gordon E. has over 30 years of experience in the medical device, pharmaceutical, biologics and compounding pharmacy industries. Gordon began their career in 1990 as a Laboratory Technician at Nelson Laboratories, Inc., where they were promoted to Associate Study Director and then to Study Director. Gordon then became the Bioburden Section Leader, QC/Validation Manager and IDs and Packaging Section Leader. In 2008, Gordon E. joined WuXi AppTec as a Senior Technical Specialist and Director of Microbial Assays and Specialized Studies, and later as the Director of Microbiology Operations. From 2016 to 2019, they worked at MiMedx as the QE Group Lead and Regulatory Affairs Manager. In 2019, Gordon E. became the President of GEM Consulting, providing consulting services in the areas of sterility assurance, contamination control, cleanrooms, microbiology, packaging, validations and other quality aspects. Gordon currently holds the role of Chairperson ISO/TC 209 - Cleanrooms and Controlled Environments at ISO - International Organization for Standardization.

Gordon E. completed their secondary education at University High School from 1982 to 1985. Gordon then attended Brigham Young University from 1985 to 1995, where they earned a Bachelor of Science in Microbiology, General. Gordon has also obtained certifications from CALISO (ISO 13485:2016 Lead Auditor, obtained in January 2020), ASQ (Certified Quality Auditor), and the National Registry of Certified Microbiologists (Registered Microbiologist and Specialist Microbiologist).