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QC Analyst

Company: Rose International
Location: Lexington
Posted on: April 11, 2021

Job Description:

and those authorized to work in the U.S. can be considered as W2 candidates. Job Title QC AnalystStart date 382021End date 972021Location Lexington, MA 02421 This role supports raw material testing as well as method introduction and compliance for the testing of raw materials for GMP use in manufacturing. This support is primarily achieved by the completion of complex projects such as material risk assessments, method development, method validations and qualifications, compendial method verification, and training analysts for routine use of test methods as necessary. The ideal candidate will possess strong interpersonal communication skills, the ability to work well in a team setting, as well as, independently. This position is primarily a project management role, where the individual must be able to meet deadlines while working with little to no supervision. Job Function and DescriptionAnalytical method development and validationAnalyze raw material samples using various compendia, test methods, and instrumentationPerforming and validating analytical techniques including HPLC, Purity Analysis, Amino Acid Analysis, FTIR, Raman SpectroscopyComplete and maintain all relevant paperwork following GDPGMP guidelinesRevise and review pertinent documentation as appropriateMay provide assistance in troubleshooting results outside of predefined specificationsMay perform other duties as assigned. RequirementsBachelor''s degree requiredAn advanced knowledge of cGMP and industry standards pertaining to Quality Control Raw Materials inspection, sampling, testing, and approval is essentialPrevious method validation experiencePrior regulatory inspection experience is necessaryIn addition, the candidate must have experience using compendial methodology, such as the United states Pharmacopeia, and the European PharmacopeiaMust have strong verbalwritten communication skillsGood computer skills, knowledge of Microsoft Word and ExcelGood interpersonal skills and be able to work effectively and efficiently in a team environment PreferredHPLC softwares would be a plus- Empower preferredPrevious experience with thermal spectroscopy preferred

Keywords: Rose International, Boston , QC Analyst, Professions , Lexington, Massachusetts

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