Quality Control Testing

Michele R Kipa

*** *********** **** 610-***-****

Collegeville, PA 19426 ***********@*******.***

Analytical Chemist

Highly organized analytical chemist with extensive experience delivering quality work in a timely fashion while managing a laboratory in a pharmaceutical environment. Strong technical skills from quality control testing and container closure testing. Excellent work ethic and capacity to adapt to increasingly responsible roles and shifting priorities. Brings commitment to continuous improvement.

Professional Experience

Merck & Co, Inc, West Point, PA 1996 - 2011

Staff Scientist (2006-2011)

Analyzed sterile processes for container closure requirements. Oversaw and managed validation laboratory.Designed and implemented new organizational systems within laboratory resulting in more efficient work flows and space management.Carried out container closure testing (microbial ingress, dye ingress, helium leak) on sterile processes, resulting in enhanced sterility assurance.Prepared technical reports documenting container closure validation.

Laboratory Data Analyst (2005-2006)

Reviewed laboratory data to ensure cGMP documentation was maintained.Evaluated 100% of raw data and final data to ensure product quality and compliance to federal guidelines while increasing right first time metrics from 65% to 95%.Investigated laboratory atypicals to produce scientifically sound reports.

Senior Analytical Chemist (1996-2005)

Performed quality control testing on raw materials, finished products, and stability samples according to quality standards and pharmacopeia.Performed analytical testing according to regulatory requirements to ensure product quality and patient safety while meeting testing deadlines and reducing cycle timeMastered and extensively utilized HPLC, UV/VIS spectrophotometer, GC, dissolution baths, and FT-IR.Maintained accurate, quality documentation skills by keeping laboratory notebook consistently at 100% right first time.

Education

M.A., Chemistry, University of Virginia, Charlottesville, VA

B.S., Chemistry, University of Pittsburgh, Pittsburgh, PA

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