Quality Control Manager

*** ***** **** ******, ********, IN ***** 859-***-**** ********.*******@****.***

Courtney C. Withers

Skills Summary

• Solid experience in technical writing and quality control testing in the pharmaceutical industry

• Experience and familiarity with concepts of Six Sigma, LEAN, and GMPs

• Proficiency with a variety of instruments:

ICP (Optima 3000 and 5300) ICP-Mass spectrometry

UV-Visible spectroscopy Fluorescence spectroscopy

Atomic absorption/emission FTIR

Gas chromatography-FID HPLC

Stereomicroscope GRIM3 microscope

• Committed to achieving the very best results in a timely, efficient manner

• Very comfortable with communicating and working with other people, from a variety of departments, on a team or project

• Able to learn very quickly, and eager to learn new processes and take on additional responsibilities

Accomplishments

• WROTE 30 NEW SPECIFICATIONS, AND REVISED SEVERAL OTHER EXISTING SPECIFICATIONS, IN A 6 MONTH TIME FRAME for Coldstream Laboratories.

• HELPED CLOSE ALL OUTSTANDING DEVIATIONS AND CAPAS within the Coldstream QC department in 2011.

• CREATED BRAND NEW TRACKING SYSTEM FOR METRICS AND KPI’S within the Coldstream QC department in 2012

• WORKED AS A MEMBER OF A SIX-SIGMA TEAM responsible for ensuring consistent and accurate results in repeated ECD-FID testing trials on methylene chloride at Avantor.

• PARTICIPATED IN KAIZEN EVENT at Avantor that created and implemented new procedures to minimize and eliminate existing problems when adding chemical stabilizer to samples of methylene chloride.

• DESIGNED AND IMPLEMENTED TRAINING MANUAL currently in use for training new employees at Planet Sun Tanning.

Professional Experience

July 2011 – February 2012 Coldstream Laboratories, Inc. Lexington, KY

QC Chemist/Document Specialist

Wrote and revised material specifications for APIs, excipients, container closures, manufacturing components, and finished pharmaceutical products.

Performed quality control testing on raw materials and container closure systems.

Tracked metrics and KPIs for quality control department to help meet company goals.

Followed samples that got sent to contract labs for testing, at every stage, from creating preliminary shipping paperwork, to following up until results were received.

October 2009 – April 2011 Avantor Performance Materials Paris, KY

(Formerly Mallinckrodt Baker, Inc.)

Quality Control Analyst

Tested manufactured chemical solutions and solvents to ensure that they met necessary specifications.

Reviewed lab documentation and reports for completeness and correctness.

Entered sample information upon receipt and released results upon completion on Avantor’s QIMS database.

Responsible for acquiring and producing assigned monthly reagents.

May 2008 – July 2008 Kentucky State Police Forensic Lab Frankfort, KY

Intern/Lab Analyst

Assisted with research projects for the Trace Evidence Section, utilizing a GRIM3 microscope to compare the refractive indices of tempered glass with the refractive indices of non-tempered glass.

Collected and labeled samples of automotive paint to send to the FBI and the Royal Canadian Mounted Police as part of paint database query (PDQ project).

July 2006 – July 2011 Planet Sun Tanning Richmond, KY

Trainer/Training Manager

Brainstormed and implemented new training procedures for employees

Calculated monthly goals and bonuses for employees

Trained and educated new employees

Education

2005 – 2009 Eastern Kentucky University Richmond, KY

Bachelor of Science, Forensic Science

Graduated magna cum laude, with honors

References

Available upon request.

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