Melissa Eitzen

Background

About Melissa Eitzen

I am currently serving as the Director of Regulatory Operations for the Institutional Office of Regulated Nonclinical Studies (ORNcS) at the UTMB. Regulatory Operations provides the independent Quality Assurance Unit (QAU), archive staff, quality control team, regulatory education center, information technology compliance analysts, and systems administration supporting Master Control electronic document management system (EDMS). My team works closely with investigators to assure regulatory compliance by implementing quality systems, developing quality management plans, and providing regulatory compliance education. I have over 35 years of laboratory development, management, equipment validation, regulatory compliance, and course development experience, and am a Registered Quality Assurance Professional in GLP (RQAP-GLP) and a registered Medical Laboratory Scientist with the American Society of Clinical Pathology, MLS(ASCP). My experience in the development of quality systems to meet regulatory requirements began in 1985 when I developed a quality system infrastructure for a new environmental testing laboratory that resulted in dual accreditation by the National Voluntary Laboratory Accreditation Program (NVLAP) and American Industrial Hygiene Association (AIHA).