Assistant Laboratory Manager
Charlotte, North Carolina, United States
• Promoted from Senior Analytical Chemist to Laboratory Manager and tasked with supervision of day-to-day operation of laboratory.• Supervised all aspects of Stability Chemistry Lab ensuring compliance to DEA and FDA regulations.• Oversaw scheduling and supervised eight Chemists and one Lab Tech.• Resolved analytical issues and troubleshooting complex laboratory statistics for quarterly reviews and forecasting budget needs in addition managing an annual laboratory budget of over $1 million a year.• Eliminated backlog of over 300 incomplete projects within first six months of employment by re-establishing in-house stability program.• Performed USP stability testing analysis using a variety of analytical techniques (i.e. HPLC, Dissolution, KF, etc.).• Responsible for all internal laboratory systems Metrology programs and management of all laboratory equipment calibrations.• Implemented controlled documentation software programs and systems for all analytical equipment used within the laboratory and streamlined documentation reporting.• Wrote Out of Tolerance, Out of Specification and Laboratory Aberrant Data Reports for investigational reports.• Authored and executed various validation protocols (IQ/OQ/PQ) for new process designs and new instrumentational equipment writing DQs, SATs and URS documents.• Authored numerous Laboratory SOPs (i.e. Data Review, LADR Investigation Reporting, Instrumental SOPs, Laboratory Documents, etc.).• Navigated FDA audit and wrote verbal responses for previously practices.• Spearheaded implementation of site Cleaning Validation Process, authoring guidelines to establish cleaning process validation for over 200 NDC products.• Established goals and KPIs.• Used KPIs to track actual performance versus goals and as a baseline for continuous quality improvement.• Served as a catalyst for positive change and transformation management.• Streamlined and re-engineered workflows and processes..
