Professional experienced in GxP Computer System Validation along with Process Validation supporting Life Science Companies (Pharmaceuticals, Bio-Techs, & Medical Devices). In depth knowledge of the Code of Federal Regulations imposed on these companies by the FDA, 21 CFR Part 11, Part 210 & 211, and Part 820. A professional able to leverage my technical knowledge & experience to write & edit technical documentation (i.e., URS, FRS, & DS documents) for SMEs. Experienced at writing validation documentation driven by the requirements for the systems.
Web Developer with a passion for creating websites for businesses local and across the country. My previous experience is working with Satellite Ground Systems and a COTS application for life science companies.