Amy BradfordValidation Scientist
MS, Microbiology, Southern Illinois University; BA, BIology, Illinois College
Amy is a goal oriented quality assurance/quality control technical professional and collaborator with over 20 years’ experience in FDA regulated industries ranging from laboratory design/operations to process compliance. She has an understanding of both API and finished product regulations. Amy has experience in compliance of major systems and equipment including laboratories/testing methods design and validation, facilities/utilities and manufacturing processes. She has expertise in the development of major quality systems including to meet ICH and FDA guidelines.
Amy has experience in validation of lab equipment and methods, major equipment, processes and utilities, including cleaning validation. She has superior skills for in process and lab investigations, CAPA management and auditing of suppliers/co-manufacturers. Her strengths include quality project management, development of training and proficiency programs, laboratory operation and method validation, cleaning and process validation, batch documentation and disposition, technology transfer, planning and organization and technical writing. Amy has understanding and application of global regulations including, FDA, ICH, MHRA and Health Canada.