Job Description
KV Pharmaceutical seeks a Process Validation Associate. The successful candidate will work with validation technology, production, and quality assurance, research and development and analytical research personnel to ensure that products produced under process validation protocols are sampled and tested in strict compliance with requirements. As the Process Validation Associate, you will maintain orderly and timely documentation, to include, but not limited to actual physical test data, process validation data tabulations. The incumbent will develop and execute written protocols for process validation of lots for commercial distribution, assure that testing is completed in accordance with Company policies, procedures and test methods, and maintain orderly and timely documentation relevant to process validation studies.
Bachelor’s Degree, preferably in a science discipline required. Quality Assurance/Control laboratory testing equipment required. Experience in inspection of raw trials, in-process and finished pharmaceutical product sampling strongly desired. The successful candidate should have experience with the following equipment: Analytical Balance, LOD Instrument, Micrometer, Friabilator, Hardness Tester, Calculator, Particle Size Analyzer, Disintegration Apparatus, and Viscometer. As a Process Validation Associate, you should have knowledge of statistical software and calculations along with knowledge of manufacturing processes, sampling techniques, government regulations and guidelines. You must have a strong understanding of GMP’s and process validation concepts, good conflict resolution skills and the ability to reach and comprehend written technical procedures as well as cGMP and SOPs. We are seeking detail-oriented individuals who possess excellent verbal and written communication skills, math skills, have strong organizational skills, can multi-task, prioritize, and are proficient in Microsoft Office.
With 13 consecutive years of record revenues, KV Pharmaceutical Company (www.kvph.com), a high-growth organization, has reported a year-over-year net revenue increase of 35.7% to over $600 million for Fiscal 2008.
KV Pharmaceutical (NYSE: KVa/KVb), is a fully integrated specialty pharmaceutical company that develops, manufactures, markets and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology-distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its emerging branded drug subsidiary. With more than 65 years in business, KV applies its 15 unique patent protected and proprietary drug delivery technologies to both the brand and generic/non-branded products.
KV is based in St. Louis, Missouri, which was recently named as a 2008 All-America City by the American City Business Journals, one of Forbes’ “200 Best Metropolitan Areas” in America in 2006. St. Louis was also named the second most affordable large metropolitan area in the country by the National Association of Home Builders in 2005. St. Louis offers a world-class medical community with over 50 general practice, teaching and research hospitals including Washington University and St. Louis University. St. Louis is also rich in education with more than a dozen nationally-recognized four-year universities.
KV Pharmaceutical provides a comprehensive benefits package including a 401(k) and profit-sharing, health, vision, and dental. We offer competitive salaries and stock options for many positions which have proven to be lucrative to many long-term KV employees.
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