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QCTS Scientist II

Company: Sanofi
Location: Framingham
Posted on: May 10, 2022

Job Description:

QCTS Scientist IIJOB OVERVIEW:Provide lifecycle management for critical reagents, qualified materials, and analytical reference standards used by QC customers. Author documents (protocols, SOPs, and reports) and evaluate QC results. Develop reagent program strategy in consultation with colleagues.JOB RESPONSIBILITIES:Assist in the lifecycle management of critical reagents, qualified materials (such as assay controls), and analytical reference standards used by Quality ControlAuthor complex documentation, including SOPs, protocols, and technical reports incorporating appropriate use of statisticsEvaluate data for compliance to procedures and specificationsIdentify potential problems and proactively suggest solutions based upon analytical expertise and knowledge of product/processProvide program compliance and audit supportJOB REQUIREMENTS & QUALIFICATIONS:Bachelor's degree in a scientific discipline and 8 years relevant experience, or equivalentor Master's Degree in a scientific discipline and 5 years of relevant experience in a cGMP lab environment, or equivalentor a PhD in Life Sciences discipline and 2 years experience in cGMP lab environmentKnowledge of USP and global compendial regulations and requirements for method life cycle activitiesExperience in qualifying (or managing qualification of) critical reagents, qualified materials (such as assay controls), and analytical reference standardsScientific technical writing ability including authoring and revising SOPs, qualification Protocols, and technical reportsEffective oral and written communication skills (English Language)Proficient in MS Outlook, Word, and ExcelTERMS OF EMPLOYMENT:Occasional travel (

Keywords: Sanofi, Framingham , QCTS Scientist II, Other , Framingham, Massachusetts

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