Sanofi Group Quality Senior Specialist , Night Shift - 12 hour Rotating - 7PM-7AM, Allston, MA in Allston, Massachusetts

**Night Shift - 12 hour Rotating - 7PM-7AM

This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's.

Responsibilities include:

  • Performing record review necessary in ensuring the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor

  • Conducting reviews of manufacturing processes to ensure compliance

  • Conducting reviews of testing results in support of release of intermediates

  • Assisting in deviation/nonconformance identification and resolution

  • Participating on team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution

  • Interpreting complex, explicit documentation to ensure quality standards and compliance

  • Providing training to new employees

Basic Qualifications:

Bachelor's Degree and 5 years of experience, or Associate's Degree and 7 years of experience, or 5 years of experience in the BioTech / Pharmaceutical Industry. Minimum 1 year experience within Quality Control, Manufacturing, or equivalent role.

Preferred Qualifications:

  • Fully versed in CGMP, ICH, EMA and FDA rules, guidance and expectations. Experience in on the job training and authoring SOPs.

  • Experience with using operational excellence tools to drive continuous improvement Strong computer, verbal and written communication skills.

  • Strong technical writing skills.

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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life