Upon earning a degree in Zoology at North Carolina State University, I began working in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing. My work allowed me to move into a supervisory role at Abbott Laboratories where I oversaw the Quality Control Lab. In 1998 I moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, holding annual GMP training for new employees, and writing audit report, and SOPs. After working in Quality Assurance for a few years, I moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
With 12 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, I have gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, and Technical writing. I have written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. I also develop and deliver webinars, on-site training, and seminars for training in areas such as Technical Writing, Equipment Qualification, Cleaning Validations, FDA Audit Preparation and more.
In 2013 I started my own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.