Marta e Gonzalez-Pineiro

Background

About Marta e Gonzalez-Pineiro

I have 30 years of experience combined in pharmaceutical sciences and regulatory affairs. Since I was in college I search for opportunities in research to be able to have enough experience to find a job related to science. I did hydroponic In Vitro growing of rice plants to make them resistant to different soils and environment. After completing my BS in Biology, I was hired by Abbott Pharmaceutical, Inc, as a Validation Technician and I learned the manufacturing process of semi-solid dosage forms (tablets, capsules, API, powders). Also, one of my responsibilities was sample testing of drugs in different manufacturing stages, cleaning validation of equipment, and cross contamination studies. Also, I was in charge to enter QA/QC data and do statistics analysis of this data that were part of the validation package requirement from the Food and Drug Administration (FDA). This experience gave me an interest in regulation. In 2002, I was an intern with the Hispanic Association of College and Universities (HACU) and got an opportunity to work with FDA. Currently, I am celebrating 22 years of service with the FDA where I gained knowledge in drug inspections, CGMPS regulations, drug labeling, recalls, exportation of drugs, customer services, computer programs, trades, public health, and regulatory affairs.