Senior Scientist
HOFFMAN – LA ROCHE, Nutely, New JerseySenior Scientist, 2000 to 2010Spearheaded clinical QC program to ensure consistent product quality, establishing quality processes and standards across development, testing, validation, audit, and issue resolution. Managed quality-focused data collection in alignment with regulatory compliance requirements, including defect log and data entry in Trackwise; collaborated extensively with FDA and third-party consultants on audits, finding analysis, and… Show more HOFFMAN – LA ROCHE, Nutely, New JerseySenior Scientist, 2000 to 2010Spearheaded clinical QC program to ensure consistent product quality, establishing quality processes and standards across development, testing, validation, audit, and issue resolution. Managed quality-focused data collection in alignment with regulatory compliance requirements, including defect log and data entry in Trackwise; collaborated extensively with FDA and third-party consultants on audits, finding analysis, and corrective action planning. Delivered a 25% reduction in product failure rate through intensive root cause analysis and process improvement; introduced an error protection program. Participated in international, cross-functional teams to investigate quality deviations, implement new QC methodologies, affect technology transfers, and ensure regulatory compliance. Played instrumental role in operational excellence initiative which achieved a dramatic reduction in cost per unit, from 17 to 7 cents per tablet. Set up laboratory operations for HPLC mobile phase; slashed analysis times by 50% and increased expiry date from 7 to 30 days. Recognized with multiple awards for exceptional performance, including completing 4th quarter revenue push, effectively handling FDA inspection, performing annual inspection with quality management leadership team, and dedicated commitment to volunteer work. Show less