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Chemical Manufacturing Implementation in: Lab Safety, Quality Control, SOP, SAP, Patents, and Manufacturing Expert

Technical Consultant #1416


Expertise

  • Method development, troubleshooting quality control, and validation for chemical manufacturing.
  • Linking LIMS (laboratory information management systems) and SAP for integrated lab systems.
  • Laboratory safety.
  • Standard Operating Procedures; staff training and evaluation in testing methods.
  • Construction of internal audit programs for continuing evaluation of laboratory operations.
  • Translation of chemical procedures from German.
  • Malvern particle size (laser diffraction).
  • Color Measurement (Xrite MA68II, Datacolor multiangle instrument, Minolta CR-400)
  • GC, HPLC, FTIR, electrochemistry, XRF, wet chemical techniques.

Experience

Chemical Consultant, 2018 - Present 

  • Assisting with presentations on patent-pending device, as part of NSF grant application.
  • Prepared and reviewed SDS for GotGreen® Plant-Based Foam Soap.
  • Determined the multi-step synthesis route from several linked patents, per client request.
  • Literature research. 

Undisclosed University, Chemistry Instructor, 2018 – Present

  • Teaching university-level freshman chemistry majoring in technical disciplines.

EMD Performance Materials, Savannah, GA, 1995 - 2018

Methods Development 

  • Designed a three tier Internal audit program tailored to the site processes.
  • Constructed calibration program for over fifty instruments, which became part of the qualification for ISO certification of the site.
  • Set up the first validation system for the QC dept, which lead to product approval by FDA.
  • Coordinated gage R&R on instrumental methods for 6 teams of technicians, enabling teamwork by setting group and individual goals for acceptable and exceptional results.
  • Designed new tests and adapted standard tests which supported new product introduction and increased speed of analyses, working closely with the manufacturing support and product development departments.
  • Introduced new methodology and instrumentation from corporate QC in Germany to the QC department.
  • Trained software-driven instrumentation uses to technicians unfamiliar with computers.
  • These instruments included GC, automated analyzer, FTIR, HPLC.
  • Assisted customer service and product management with new product documentation as well as with customer requests, questions, and complaints.

LIMS Administrator

  • Quality Control LIMS Administrator (Labvantage, Starlims)
  • Trained department on LIMS.
  • Created reports in LIMS using Access and Crystal Reports, converting QC from gathering data from paper sources to electronically mining and presenting data.
  • Lead the laboratory team that implemented Starlims; as LIMS administrator, educate all sites on Starlims use and adaptation.
  • Revised database formatting of existing products in time to meet product management deadlines.
  • Created instrument link between Starlims and Malvern particle size instrument. This work reduced the sequential entry of three values per lot in LIMS to one export function from Malvern and one button click in Starlims for all lots.

SAP Key User and Data Owner 

  • SAP Key User in Quality Management; member of corporate-wide team to implement North
  • American rollout of SAP and later international integration; principal trainer on SAP QM.
  • Assisted in creating a link between LIMS and SAP, which increased efficiency by allowing the user to both create the COA from the LIMS and to release material in SAP, all while still in the LIMS environment.
  • Trained end users in two sites in QM.
  • Created SOPs for SAP use.

Statistics 

  • Produced process capability reports for supplier scorecard using Statgraphics and Minitab. Data was gathered electronically as well as from sister sites. The customer’s product quality report scored 10 of 10 points in this section.
  • Created EMD method validation package as part of a successful FDA qualification of pigments as excipients in food and personal products.
  • Coordinated gage R&R for six methods using one team per method. Enabled teamwork by negotiating group goals for acceptable and exceptional results and by scheduling performance.

Chemical Hygiene Officer 

  • Created and maintained site specific Chemical Hygiene Plan

Georgia Southern University, Statesboro, GA, Visiting Instructor, 1995 - 2018

  • Taught freshman chemistry classes and labs of both science and non-science majors.

Baxter Healthcare Corporation, Kingstree, SC, Chemical Laboratory Supervisor, 1991 – 1995 

  • Supervised 3 labs and 9 technicians in quality assurance for finished products and in-process.
  • Chemical Hygiene Officer for the site, putting in place the first CHP.
  • Trained technicians on software-driven equipment, including GC, automated analyzer, FTIR, HPLC.

Chemical Hygiene Officer

  • Created and maintained site specific Chemical Hygiene Plan.
  • Backup Environmental Manager, assisting Manager with environmental compliance for the site.
  • Acted as Manager during his absence. 

Hunt-Wesson Corporation, QC Technician, Savannah, 1990 - 1991

Union Camp Corporation, Methods Development Chemist, Savannah, GA, 1989 - 1990

Chemical Hygiene Officer

  • Created site specific Chemical Hygiene Plans for two companies.

Educator

  • ACS course Laboratory Safety, Methods Development and Validation.
  • Practical Management Inc. – Teaching Technical Topics.
  • American Management Association – Improving Your Project Management Skills.

Honors & Publications


Credentials

  • Certified Chemical Hygiene Officer (National Registry of Certified Chemists)
  • American Chemical Society Short Course on Method Validation
  • American Chemical Society Short Course on Laboratory Health and Safety
  • American Management Association: Improving Your Project Management Skills
  • Practical Management Inc.: Teaching Technical Topics
  • Measurement Systems Analysis (MIC Quality)

Languages

  • Fluent in German. 

 Professional Affiliations

  • American Chemical Society, Section Chair

Education

  • M.S. Analytical Chemistry, Miami University, Oxford, OH
  • B.A. Chemistry, Wright State University, Dayton, OH
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