Lise Van Winkle

Lise Van Winkle

Work History

Work History
Jun 2009 - Jun 2012

Director of Operations/Quality Assurance Manager

MedworksRx
  • Managed repackaging operation ensuring accurateness, timeliness and good customer relations.
  • Created documentation necessary to fulfill requirements by the Drug Enforcement Administration (DEA), Food and Drug Adninistration (FDA), and State Boards. 
  • Created and maintained all Standard Operation Procedures (SOP’s) necessary for a Repackager facility and operations in accordance with Current Good Manufacturing Practices (cGMP) ruling. 
  • Helped implementing SOP’s in preparation for FDA inspection and streamlined SOP’s in connection with a facility move.
  • Organized and set up a manageable procedure for keeping current licensing internally and externally.
  • Utilize Microsoft Excel, Access, Word, Traker, SuiteRx, Label Flow, and ARCOS software.
May 2002 - Jun 2009

CFO

J & S International
  • Created and managed day to day financial attributes of company. 
  • Responsible for government and corporate tax issues, corporate invoicing, accounts payable, accounts receivable, bank reconciliation, sales and payroll tax.
Sep 1995 - Apr 2001

Scientist II

BioCryst Pharmaceuticals
  • Worked with a team of scientist creating and evaluating drug formulations including: iv-solutions, eye drop solutions, creams, capsules and tablets for clinical trials.
  • Created SOP’s for equipment used and managed stability studies.
  • Used High-Performance Liquid Chromatography (HPLC) and Ultraviolet Spectrophotometry (UV-VIS) in the validation performances.
  • Co-authored several publications incl. “Preformulation studies for the development of a parenteral liquid formulation of the immunomodulator, peldesine”, PDA Journal of Pharm, Sci. and Tech., 53, (1999) 303 – 308.
Aug 1993 - Aug 1995

Analytical Chemist/Chemist

Avanti Polar Lipids

Analytical Chemist, (6/94 – 8/95)

  • Performed quality control procedures on raw materials, intermediates and final products utilizing equipment and methods including Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), Thin Layer Chromatography (TLC), Atomic Absorption (AA), Ultraviolet Visible Spectrophotometry (UV-VIS).
  • Developed new analytical methods and Standard Operation Procedures (SOP’s).

Chemist, (8/93 – 5/94)

  • Synthesized lipids on a production scale while researching new methods and procedures for present and future production.
Apr 1992 - Jul 1993

Research Assistant

Auburn University

Research Assistant, Department of Chemistry (1/93 – 7/ 93)

Research Assistant, Department of Civil Engineering (4/92 – 12/92)

  • Studied toxicity and later the origin of compounds released during both the ozonation and chlorination methods of decolorization of textiles.

Skills

Skills

Microsoft Excel

Education

Education
Aug 2012 - Present

University of Alabama

I am pursuing a Masters Degree in Nutrition

Sep 1993 - Present

Jefferson State Community College

I have taken classes at Jefferson State Community College since I arrived in Birmingham. The classes range from english writing to accounting to prerequisites to apply for the master program in Human Nutrition at the University of Alabama.

Sep 1986 - Mar 1993

Master of Science

The Royal School of Pharmacy

Thesis titled Toxicity Study on the effect of Ozone Treatment of Textile Dyes. Research included work performed at the Department of Civil Engineering at Auburn University, Auburn, Alabam