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Quality Control Analyst II

Framingham, Massachusetts



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Job Overview:

The Quality Control Technical Services (QCTS) function is to develop (phase 2), validate, transfer, and support life cycle of analytical methods; trouble-shoot methods for Quality Control Laboratories globally; and to support regulatory submissions and post-approval commitments.

Position Summary
This position is primarily responsible for executing methods and procedures for the QCTS laboratory with supervision.

Core Responsibilities

  • Perform testing in accordance with SOPs, relevant procedures and/or protocols for method development (phase 2), method verification, method validation, method transfer, process development support, equipment qualification, and investigation support as required.
  • Perform maintenance and performance verification of laboratory equipment.
  • Perform investigation of laboratory events with supervision.
  • May support investigation of deviations (as applicable) and completion of CCR and CAPA tasks.
  • Review data for compliance to procedures and specifications.
  • Participate in writing and revising SOPs for methods and QCTS equipment with supervision.
  • Perform data analysis.
  • Work under close supervision and direction.
  • Adhere to Sanofi GMP and safety procedures and guidelines.

Requirements & Qualifications:

  • Bachelor's degree in a scientific discipline and 2+ years of relevant experience executing one or several of the following technologies (e.g. HPLC, GC, electrophoresis, spectroscopy, ELISA), orequivalent.
    • Strong oral and written communication skills (English Language).

Preferred Qualifications:

  • Basic knowledge (i.e. 2 or more years experience) in executing one or more of the required method platforms (e.g. HPLC, GC, electrophoresis, spectroscopy, ELISA).
  • Proficient in MS Outlook, Word, and Excel.
  • Effective written and verbal communication skills.
  • Experience in cGMP lab environment.

Terms of Employment:

  • Ability to perform laboratory work using chemicals as required.

  • Ability to occasionally lift up to 25 lbs.

  • Travel (10%+) may be required to provide on-site support to Biologics QC laboratories for trouble-shooting support.


Framingham, MA

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.




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