Quality Assurance Laboratory Supervisor
Edison, Nj 08817 (Location Now Closed)
QUALITY ASSURANCE LABORATORY SUPERVISOR, 1991-2007Directed/supervised operations of QA (Quality Assurance) function and laboratory, including review and validation of methods used in the laboratory, training/mentoring of technicians, calibration program and statistical analysis. Managed disposition of raw materials and finished products. Performed audits against ISO 9000: 2000, GMP and corporate internal quality systems standards. Audited selected suppliers. Designed and produced management reports on process performance, operations metrics, and quality. Selected, configured and managed laboratory information management system. Audited GMP compliance in operations in both Edison location and Wrigley Americas facilities.Performed vendor audits of critical raw materials and packaging.Managed customer complaint system.Key individual in validation of process line for products for pharmaceutical formulations.Certified ISO 9000:2000 Internal Auditor. Certified as Supplier Auditor by the Corporate QA group.Certified as internal quality systems auditor and auditor trainer by the Corporate QA group.Cost Improvement-Reduced QA manpower requirements by 50%, saving $125,000 a year.Moved from three-day testing delay to delivery from truck to factory floor. Saved $230,000 a year.Qualified as Six Sigma Green Belt.Investigated, tested and implemented online near-infrared reflectance (NIR) technology to provide manufacturing with continuous information on product parameters.Selected, configured and managed laboratory information management system (LIMS).Designed satellite factory lab, trained employees and maintained oversight of operations.Managed set-up and qualification of testing laboratories in new facilities in both Georgia (USA) and Shanghai, China, including training, qualification program design, specification of equipment and layout, post qualification support and knowledge transfer.