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Quality Analyst II

Company: Stefanini
Location: Parsippany
Posted on: November 23, 2021

Job Description:

Stefanini Group is looking for a Quality Analyst in Parsippany NJ that can start ASAP. Exciting opportunity awaits for you! Let us help you get started. Please click the apply button below or call 248-728-2613/email: Yudishree.Shetty@stefanini.com for faster processing! Position SummaryResponsible for insuring that all drug, biologic, combination or device products produced by Teva's Third Party external manufacturing and packaging partners meets the established standards of quality including reliability, usability and performance. Key ResponsibilitiesEnsure ongoing compliance with quality and industry regulatory requirements for cGMPs, 21CFR 210/211, 21CFR 820 and 21CFR Part 4.Responsible for release of product manufactured and/or packaged at Teva's Third Party Suppliers located in the U.S.Receive, review Quality Customer Complaint investigations, non-conformance reports, Deviation Investigations and Laboratory Investigations ensuring all necessary components are included.Review, evaluate and approve change controls from Third Party Suppliers and act as the point of contact for all comments between internal departments and the site. Education and Experience:Bachelor's degree with a minimum of 3 years' experience in a Pharmaceutical FDA regulated industry in Quality Assurance or related field.Must have working knowledge of cGMPs, CFR, ICH and applicable international regulations/guidelines.Experience with Investigations (Manufacturing and/or Laboratory), Change Controls, Product Release, CAPA, preferred.

Keywords: Stefanini, New York , Quality Analyst II, Professions , Parsippany, New York

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