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Sanofi Group Quality Control Validation Scientist in Framingham, Massachusetts

POSITION OVERVIEW

Job Summary

Quality Control Validation Scientist I is responsible for the qualification activities, following SOPs and regulations including Data Integrity, related to one or more of the following areas: IQ, OQ, PQ and requalification.

Core Responsibilities

  • Perform qualification in a cGMP biotech facility managing multiple complex qualification projects and providing technical assistance to less experienced team members.

  • Write, review and approve qualification protocols and reports as well as execute protocol. Resolve protocol discrepancies and deviations.

  • Evaluates new tecnologies platforms for implementation in the QC Laboratories.

  • Ensure GMP compliance of all activities performed.

  • Represent QC Validation in internal and external audits as required.

  • Ensure appropriate facility support and provide technical expertise with regards to equipment.

  • Review standard operating procedures.

  • Maintain positive relationship and network effectively across sites and organizations.

  • Provide project oversight and participate in cross-functional teams.

  • Practice safe work habits and adhere to Sanofi's safety procedures and guidelines. An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Perform other additional job related duties as required.

  • Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our Company policies and procedures.

  • Being honest and treating people with respect and courtesy.

  • Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products.

  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Skills

  • Knowledge of Validation Lifecycle Approach.

  • Knowledge of Validation Data Integrity Principals

  • Ability to present technical data.

  • Ability to work independently on scientific projects.

  • Scientific technical writing ability authoring and reviewing SOPs, qualification protocols and technical reports.

  • Experience troubleshooting of assay and equipment issues

Education

  • Bachelor’s degree in Life Sciences discipline and 5 years of experience in cGMP lab environment, or

  • Master’s degree in Life Sciences discipline and 3 years’ experience in cGMP lab environment.

  • PhD in Life Sciences discipline and 0-3 years’ experience in cGMP lab environment

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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