Senior Chemist
CurrentSupported quality management systems towards onboarding new GMP drug products, and laboratory equipment lifecycle from IOQ to decommissioning. Authored and reviewed reports, SOPs, non-conformances, CAPA and deviations; performed effectiveness checks, root cause analysis/gap analysis, and executed change controls, assessments and action items, including preparing metric reports. Managed internal and external laboratory investigations including performing analytical data review/compliance review. Supported business operations by driving quality improvement projects to reduce waste and increase value add, and coaching cross-functional 6s lean six sigma team. Slashed activation time of QC testing resulting by 7000+ hours of annual time savings across personnel by implementing visual management and PowerApps for correction tracking. Implemented internal audit program and standard work to drive audit readiness ensuring regulatory compliance.Transformed new employee onboarding by developing structured training program with robust qualifications to ensure proficient performance, and value-added customer delivery.
