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Quality Control Manager

Location:
Omaha, NE
Posted:
May 11, 2015

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Resume:

Summary

Fifteen years of experience as a lead researcher/principle scientist with

eight years in management. Comprehensive knowledge of quality control

derived from experience and continuing education.

Pennfield Animal Health, Omaha, NE 2006 to Present

Quality Control Manager

. Enact quality control measures to ensure efficient and accurate result

reporting in the laboratory

. Organize and prepare lab testing for experimental procedures

. Provide daily technical guidance and mentoring to staff

. Complete investigative reports to include root cause analysis and CAPA

. Provide training to staff on laboratory methods

. Initiate method development for several new drugs

. Maintain SOPs relevant to Quality Control

. Oversee validation programs including manufacturing process

validations and method validations

. Write and review deviation and investigation reports

. Audit off-site manufacturing facilities and laboratories to ensure 211

and 226 products are manufactured and tested in accordance with cGMPs

. Oversee the stability program and provide all necessary documentation

for regulatory to submit in annual reports

Pennfield Animal Health, Omaha, NE 2004 to 2006

Quality Control Scientist

. Compile and document test findings and results

. Prepare all reagents used in laboratory experiments and methods

. Follow SOPs according to cGMP regulations

Schering-Plough Animal Health, Elkorn, NE 2002 to 2004

Lab Technician

. Performed cell culture using sterile techniques

. Observed cell lines daily

. Formulated blends for FeLV production

. Updated various SOPs and provided training

. Inoculated cell lines with viruses for use in production of vaccines

. Optimized various procedures and increased titers with experimenting

on inoculating and harvesting time

Creighton University, Omaha, NE 2001 to 2002

Senior Lab Technician

. Assited in skin cancer research through the use of DNA extraction, gel

electrophoresis, and western blotting.

. Performed cell culture using sterile techniques

. Followed detailed experimental protocols

. Successfully genotyped mice colony in timely manner to separate

appropriate mice to achieve specific results

Martec Pharmaceutical, Inc., Kansas City, MO 2000 to 2001

Analytical Chemist

. Performed titrations, assays, dissolutions and impurity testing on

products

. Operated HPLC, FTIR, UV, and GC

. Calibrated instruments monthly

. Organized and complied reports based on testing results

Education

University of Nebraska at Lincoln, Lincoln, Nebraska 1999

B.S., Veterinary Sciences

Nebraska Wesleyan University 2014

Master of Forensic Science



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