Testing Facilities Manager (TFM)
Karen Hughes is a member of the Testing Facility Management (TFM) team at the University of Maryland School of Medicine (UMSOM). She is contracted through Meridian BioGroup, a regulatory and compliance contract service provider to the biotechnology and pharmaceutical communities. She is a performance-driven and accomplished Quality Assurance Professional with 30 years of experience in the pharmaceutical, biotechnology, and medical device industry. She has worked in GLP, GMP, GCP, ISO, and DEA environments at Synthetic Biologics, Pharmaceutics International, Inc., Emergent BioSolutions, MGI Pharma (formerly Guilford Pharmaceuticals), and Chesapeake Biological Laboratories, and is knowledgeable in the associated regulations and ICH guidelines. She is skilled in the development, implementation, maintenance, and continuous improvement of Quality Systems in regulated environments during start-up and throughout product life cycles.
Quality Assurance Unit (QAU)
Michelle Ross functions as the Quality Assurance Unit at the University of Maryland School of Medicine (UMSOM). She is contracted through Meridian BioGroup, a regulatory and compliance contract service provider to the biotechnology and pharmaceutical communities. She has a B.S. degree in Microbiology from the Pennsylvania State University. She is a Black Belt Six Sigma trained professional and has more than 15 years of experience in Quality Engineering supporting the manufacturing of Medical Devices and Pharmaceuticals. Michelle has been employed with TycoHealthcare, Smith & Nephew, Zimmer, W.R. Grace, and Emergent BioSolutions. She has held certifications through the American Society for Quality in the following areas of expertise: Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Technician.
Program Manager of Document Control
Susan Messics has 9 years of GLP experience. Mrs. Messics received her BS from the University of Maryland in Animal Sciences. Mrs. Messics worked for 20 years with the Department of Defense specializing in the development of drug screening assays for the purpose of screening potential antidotes to chemical warfare agents. She worked at Pennsylvania State University in the Animal Diagnostic Laboratory assisting with the setup of a quality assurance system to include QA records, SOPs, and a web-based QA Data Management system. Mrs. Messics worked in the Department of Translational Radiation Sciences department at UMB and was responsible for setting up a GLP laboratory. Currently, she serves as the Program Manager responsible for document control and also is the Archivist for UMB.