Medical Device Quality Control

Phaedra Kilbourn

**** **** ********** ***, **** Lake City, Utah 84105•801-***-****•**********@*****.***

Objective

To find a position in a pharmaceutical or medical device company where I can apply my knowledge and experience in Quality, chemistry, and management

Experience

Oct 2009 - present Ultradent Products, Inc South Jordan, Utah

Quality Control Manager

Manage the activities of the QC analytical and microbiological departments of 35 people

Maintain standards of cGMP, MHRA, and ISO 9000 while keeping pace with an LEAN international

medical device and cosmetic manufacturing facility

Represent QC in FDA, MHRA, ISO, and client audits

Work closely with Regulatory in preparation of international medical device and drug applications

Sept 2004 – Sept 2009 BTG Salt Lake City, Utah

Quality Control Manager

Ensured quality of analytical and microbiological testing of an aseptically filled parenteral chemotherapy drug in phase II clinical trials

Conducted OOS and CAPA investigations to determine root cause, recommend and implement

corrective and preventative actions

Created and maintained systems and all associated documents for the operation of a cGMP QC

laboratory required to do material inspection/sampling/testing, bulk intermediate testing, finished

goods, and stability testing which would meet FDA, and MHRA requirements

Qualified laboratory instrumentation and directed the validation of tests methods

Sept 2002 – Sept 2004 BTG Salt Lake City, Utah

Laboratory Supervisor

Performed testing of raw materials, in-process intermediates, finished goods, and stability samples

Purchased and maintained instruments (HPLC PDA/RID and GC FID/ECD)

Supervised several chemists to prioritize work and assist in troubleshooting

Sept 1993 – Sept 2000 Energy and Geosciences Institute Salt Lake City, Utah

Chemist

Developed GC and HPLC methods to analyze for gas phase and liquid phase geothermal tracer

compounds

Tested tracer study samples which produced data that was used to make production decisions

Conducted a liquid phase tracer study at GeotherEx power plan in Dixie Valley, NV

Education

1988 - 1993 University of Utah Salt Lake City, Utah

B.S. Chemistry

Professional emphasis

801-***-****•**********@*****.***

Phaedra Kilbourn

References

References are available on request.

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