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Jobs » Biotech & Science

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Method Transfer Specialist

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iption:   Facilitate and manage multiple method transfer studies between Suffern and, E. Hanover and Lancaster labs.   Secondary role will include writing SOPs and other quality documents associated with the project.       Collect and distribute method transfer samples and reference standards and documents to the giving and receiving laboratories. Ensure alignment with associated change controls. Ensure project time lines are met. Ensure timely escalation of method transfer issues. Collect and create data tables for inclusion into method transfer reports. Preliminary evaluation of method transfer     Create or update SOPs and other quality documents required to support the move and operation of the US Stability Hub and retain program from Suffern, NY to E. Hanover, NJ     Requirements:   5-7 years experience in pharmaceutical, medical device, or related industries or other highly regulated industries Solid understanding of pharmaceutical regulations governing change control, validation, product transfer and analytical methods.   Previous experience with Trackwise is a plus Experience managing multiple documents/projects simultaneously       Education:   B.S. in Science, Engineering or Technology    

Montana, United States

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