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Jane Parks

1896 Mignon Avenue, Memphis, TN 38107 jp7d8054@westpost.net 901.355.1389


Summary For over 20 years, I have held positions of increasing responsibility wi
thin highly regulated environments. My experience is diverse and includes direct
exposure with USDA, FDA, cGMP, ISO, and customer's quality requirements. I have
worked in a variety of functions within a single job title, responsible for Qua
lity Systems and Regulatory Compliance, always with a firm belief in continuous
improvement. I have excellent communication and analytical skills, enabling me t
o work well in a technical environment, as well as interface effectively with cr
oss-functional quality teams.

Experience QA Laboratory Manager


June 2005 - Present KIK Custom Products, Memphis, TN
Manage the Quality Assurance Laboratory, overseeing the Quality Systems and req
uirements of a manufacturing plane of 350+ employees.
Conduct cGMP / Quality Audits monthly and work with cross-functional teams to e
nsure Quality Management goals are being met.
Train, manage, and develop quality personnel to operate in compliance with cGMP
/ FDA Regulations.
Provide technical support, making specific recommendations as to the testing an
d adjusting of raw materials and bulk formulations.
Maintain the department to comply with GMP, USP, and the customer's quality spe
cifications.
Validate new analytical methods, and write/update SOP's as needed.
* On call 24/7 to provide quality and technical support for the laboratory, comp
ounding, and production.
Assist with investigations of OOS raw materials/finished product, helping to de
velop corrective and preventative actions.
Interface with customers to resolve quality issues, specification changes, and
provide technical advice.
Oversee/perform calibrations, maintenance, troubleshooting of laboratory instru
mentation.
Train entry-level laboratory technicians and chemists in methods and hands-on t
raining in GC, HPLC, UV-VIS, FTIR, and Viscometers.

Laboratory Manager
January 2003-June 2005 Anresco, Inc., Fort Lauderdale, Florida
Primarily responsible for all aspects of the daily operation of an agricultural
testing lab.
Interface with clients, and schedule sampling for the FDA detention samples.
Responsible for laboratory safety and health, as well as safe and legal disposa
l of laboratory wastes.
Responsible for interviewing, hiring, and training of new employees.
Responsible for maintenance, troubleshooting, and repair, whenever possible, on
lab equipment.
Provided customer contact, as well as acted as a liaison between our clients an
d the FDA.
Performed and supervised HPLC, GC, and GC/MS assays for pesticide residues and
mycotoxins.
Prepared packets for samples on automatic detention to be submitted to the Atla
nta and Miami offices of the FDA, becoming the "test lab" for submitting the pac
kets by electronic submission.

Chromatography Laboratory Manager


October 1996-January 2003 CII Laboratory Services, Kansas City, MO
Created a chromatography lab, which included evaluating which equipment to orde
r, designing the lab layout, ordering expendables, and evaluating which assays t
o initially focus upon.
Developed an HPLC method for the analysis of Folic Acid, working with Dr. Jeann
e Rader, FDA Washington, who validated it using the official microbiological met
hod.
Assisted in designing both a quality control and chemical hygiene that resulted
in our becoming ISO certified.
Assayed for Vitamins by HPLC (B1, B2, Niacin, Folic Acid, Ascorbic Acid, and Vi
tamin A)
Assayed for Mycotoxins by HPLC and TLC (Aflatoxin, Vomitoxin, Ochratoxin, T2, a
nd Zearalenone)
Maintained and repaired, when possible, all instrumentation.
Interfaced with clients to insure their needs were being met.
Served as an officer for AACC.

Supervisor Chemist, Pesticide Residue Lab


March 1989-October 1996 Barrow-Agee Laboratories, Memphis, TN
Insured that GLP, FDA, and USDA methodologies and quality assurance guidelines
were followed by analysts.
Researched and adapted methods for new analytical procedures to be used in the
lab.
Assayed for Pesticides, Herbicides, PCB's, and Volatiles by GC and HPLC per app
ropriate USDA, FDA, AOAC, or AOCS methodology in a variety of agricultural/food
matrices.
Performed TLC analysis for Sulfonamide residues in meat.
Participated in USDA check program for Organochlorine Pesticides, PCB's, and Su
lfonamides.
Performed maintenance on GC's, HPLC's, autosamplers, and columns.

Education B.S. Biology


30 hrs. in Chemistry
References References are available on request.

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