Chemical Lab Manager Expert: Plastics, Ion Exchange Resins, Bulk Pharmaceuticals and Agricultural Herbicides

Technical Consultant #1689


Expertise

  • Senior quality control and quality assurance manager with extensive experience, including plastics, ion exchange resins, bulk pharmaceuticals and agricultural herbicides.
  • Managed three quality control laboratories in the past twenty years with up to eight chemists and analysts.
  • GC, HPLC and FTIR, including training, troubleshooting and method development procedures.
  • Installed and managed client server, TotalChrom Lab Data and control system.
  • Managed in-house and contract quality cGLP assurance and control lab.
  • Developed new test methods and introduced new "Fast GC" methodology.
  • Helped to develop a LIMS system to collect data electronically from major instrumentation, instituted use of system in lab.
  • Developed new optical lab instrument, with third party for plastics contamination testing.
  • Led Site SAP implementation team.
  • Site Quality Manager, ISO 9000.

Experience

Undisclosed Company, 1989 - 2009

Quality Control Laboratory Manager, 1998 - 2009

  • Managed a 24/7 laboratory with up to 5 analysts.
  • Restructured QC lab, converting it from a five-plus day to a 24/7 operation.
  • Cut analysis time by two-thirds on finished products in response to increased production rates.
  • Managed installation of new HPLC's, developed new methods, to support new high purity product lines.
  • Maintained 100% first pass quality through the development of quality-training procedures.
  • installed and managed client server TotalChrom Lab Data and control system.
  • Led Site SAP implementation team through highly successful transition.
  • Acted as Quality Manager for the site.
  • Site Security Officer for SAP/ERP.

Quality Assurance/Quality Control Manager, Bulk Pharmaceuticals, 1994 - 1998

  • Managed in-house and contract quality cGLP assurance and control lab.
  • Responsible for cGLP operated lab analysis meeting FDA requirements.
  • Co-developed cross contamination test procedures to meet FDA mandated cGMP requirements.
  • Developed and managed custom COA system for site Bulk Pharmaceuticals.
  • Participated as Quality Control lead in team to successfully transfer the Bulk Pharmaceuticals to single site for all regulated products.

Quality Control Lab Supervisor, Plastics, Plastics Additives and Bulk Pharmaceuticals, 1989 - 1994

  • Managed a twenty-four hours, 7 days a week, multi-business Quality Control Lab consisting of seven shift analysts and one chemist of a plastics, plastics additives and bulk pharmaceuticals businesses, serving an area of up to 150 employees.
  • Instituted new data management system to meet the needs of all three-area businesses (plastics, additives and bulk pharmaceuticals).
  • Changed the lab structure, split lab into functional groups but instituted cross training for optimal coverage capabilities.
  • Helped to develop a LIMS system to collect data electronically from major instrumentation, instituted use of system in lab.
  • Developed new optical lab instrument with third party for plastics contamination testing.

Henkel Corporation, (Diamond Shamrock Corp.), Morristown, NJ, Senior Chemist, 1967 - 1988

  • Created and administered distributed custom UNIX relational database system.
  • Managed Quality Control laboratory for specialty chemical plant, overseeing five direct reports.
  • Product development research resulting in U.S. Patent.
  • Served as technical representative to the process chemical industry.

Honors & Publications

Credentials

  • Minicomputers and Instrument Interfacing, Virginia Polytechnic Institute
  • U.S. Army Instructor Training, Advanced Solid State Electronics
  • Sampling Techniques for Solids - The Center for Career Development
  • GC Theory and Operation - DVCF
  • HPLC Operation and Troubleshooting - Agilent
  • GC Troubleshooting and Method Development - ACS Short course
  • ISO 9000 Audit Certificate
  • Certificate in Electronics Repair, DeVry Technical Institute

Academic and Professional Affiliations

  • Delaware Valley Chromatography Forum
  • American Chemical Society

Publications and Patents

  • U. S. patent for oil well drilling fluids.

Education

  • B.S. Chemistry, Delaware Valley College, Doylestown, PA
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