Experience

Pace Analytical

• United States
• Environmental Services
• 100 - 200 Employee

• Senior QA Data Review Specialist

  • Apr 2007 - Present

  • Inspected laboratory documents for accuracy and completeness and identify errors and omissions • Reviewed and approved various wet chemistry analyses, including viscosity, fat content, nitrogen content, and assays • Encouraged clear, complete and organized GMP documentation • Verified results of all calculations for assays, particle size, sulfated ash and moisture tests • Designed numerous Excel spreadsheets to enhance accuracy and efficiency of calculations • Ensured completeness and accuracy of LIMS entries • Communicated all potential errors to management and laboratory staff • Reviewed supplements and revisions of USP, FCC, EP, JP and BP compendia, assess impact and recommend response to all changes • Trained new data reviewers, assist others in completing assignments and meeting deadlines • Performed secondary review on records to ensure effectiveness of quality assurance processes • Verified accuracy of Out of Specification (OOS) data and investigation reports



Part Three (now Pace Analytical)

• Senior Chemist

  • 1997 - 2007

  • Perform quantitative and qualitative testing on drugs and drug delivery systems in a pharmaceutical cGMP laboratory • Proficient in a variety of instrumentation, including HPLC, GC, UV/VIS, FTIR, ICP, Soxtherms, Dissolution Baths and wet chemistry techniques • Author validation protocols, summary reports, calibrations procedures, site qualifications and SOPs to comply with FDA regulations • Trainer on many analytical methods • Perform weekly HPLC preventative maintenance • Mentoring and training of new employees • Project Coordinator



The Gillette Company: Personal Care Division

• Chemical Analyst

  • Sep 1994 - May 2001

  • Testing/approving batches/finished goods/chemical raw materials using HPLC, GC, UV/VIS Spectrophotometer and FTIR • Calculate adjustments to achieve specification of Gillette products • Maintain testing records to meet legal and FDA requirements • Troubleshooting, routine maintenance and calibration of lab instruments • Work with Quality Engineers on formulation problems • Performed Microbiological testing on raw materials, finished products and DI water • Testing/approving batches/finished goods/chemical raw materials using HPLC, GC, UV/VIS Spectrophotometer and FTIR • Calculate adjustments to achieve specification of Gillette products • Maintain testing records to meet legal and FDA requirements • Troubleshooting, routine maintenance and calibration of lab instruments • Work with Quality Engineers on formulation problems • Performed Microbiological testing on raw materials, finished products and DI water



Fisher Nut Company

• United States
• Food and Beverage Manufacturing
• 1 - 100 Employee

• Senior Laboratory Technician

  • May 1980 - Jun 1994

  • Perform microbiological and Aflatoxin testing on incoming raw product using Thin Layer Chromatography • Monitor and chart processing results to comply with FDA regulations • Identify and assign disposition of products that did not meet quality guidelines • Record inspection data and write report of irregularities • Perform microbiological and Aflatoxin testing on incoming raw product using Thin Layer Chromatography • Monitor and chart processing results to comply with FDA regulations • Identify and assign disposition of products that did not meet quality guidelines • Record inspection data and write report of irregularities