Atlanta Metropolitan Area
Highly analytical and resourceful Level-II certified Pharmaceutical Investigator with 10 years planning and leading over 110 specialized pharmaceutical inspections for Good Manufacturing Practices (GMP) Surveillance, Pre-Approval, Post-Approval, and For Cause inspections in 10 countries. Inspections have covered all dosage forms, bio-pharmaceuticals and active pharmaceuticals ingredients, both sterile and non-sterile. Efficient team leader who has been awarded by the Food and Drug Administration (FDA), Office of Regulatory Affairs. Provided guidance about GMP, FDA regulations, pertinent laws, preventive controls, policies, and industry practices to consumers, industry, and foreign counterparts. Responsible for actively providing support and offering guidance to numerous Inspectors in the FDA Pharmaceutical program. The outcome of my inspections have granted several Warning Letters, Recalls, and Import Alert actions from the Food and Drug Administration.
FOOD AND DRUG ADMINISTRATION (FDA) Pharmaceutical Consumer Safety Officer (Senior Investigator/ Team Leader), College Park, GA | February 2020 – Present Pharmaceutical Consumer Safety Officer (Investigator), Lenexa, KS and College Park, GA | January 2015 – February 2020
PHARMACEUTICAL INVESTIGATOR EXPIERIENCE: