B.S. in Chemical Engineering
MPH, Master in Public Health with an environmental emphasis
Kim has worked in the private industry as a Quality Assurance Engineer in helping a plant obtain pharmaceutical compliance with the FDA. She also worked with the U.S. Food and Drug Administration (FDA) as an investigator with the U.S. Public Health Service. Kim conducted investigations and inspections of food (human and animal) and medical device manufacturers. She was cited (awarded) to unit accommodations for her work in Operation Liberty Shield with the FDA as a Lieutenant in the Public Health Service. During her time with the FDA, she was knowledge as top investigator in her region for her work on recalls and official action cases. Kim’s regulatory experience includes manufacturing knowledge in hazard analysis, traceability, recalls, safety/quality systems, environmental sampling, quality systems inspection technique, and training other investigators. Her qualifications include lead instructor for PCQI, Seafood HACCP, Hazard Analysis risk-based, food safety plans, GMPs, industrial sterilization, and process validation.
Kim helps food companies obtain compliance through practical approach. Kim’s regulatory experience coupled with her engineering background, provides a realistic approach in coaching manufacturers to meet compliance with FDA regulated products. Whether updating to FSMA, starting off, or in need of a implementation of changes or PCQI training, Kim can bring an regulator’s reference point to quality system using her knowledge to help your business succeed.