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