Dawn McIver is the founder and President of MicroWorks, Inc. She has built the business from a one-person consulting group to a consulting team and cGMP compliant laboratory over the past twenty-two years.
Dawn has a Bachelor of Science degree in Biology from Purdue University.
Dawn has over thirty years of experience in Microbiology. Her first six years in microbiology included positions of Research Microbiologist and Microbiology Laboratory Manager for Silliker Laboratories. She then moved into the pharmaceutical industry, working for Fujisawa, USA. Responsibilities of that position included supervision of the environmental monitoring of the manufacturing facility, support of testing for facility validation, finished product testing including antibiotic assays, sterility testing, LAL testing and support of new product development.
Dawn’s project experience includes putting together environmental monitoring programs for medical device and pharmaceutical companies, setting up and managing cleaning validation programs, being part of a new product development team, writing and performing training and seminars for a number of clients, validating new cleanrooms and re-validating modified cleanrooms, validating Microbiology laboratory equipment including identification systems and KTA systems for endotoxin testing.
Dawn was the lead microbiologist on a consent decree auditing team that was utilized by a major pharmaceutical manufacturer to assist them with managing their return to sustainable compliance.
Dawn holds a patent on the MicroWorks Swab Sampling System (MSSS), which was developed to sampling cleanroom and isolator environments.
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