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Quality Control Analyst II

Framingham, Massachusetts

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Overview

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Benefits

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    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

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Responsibilities

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.

Location:

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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