Sanofi Group Quality Control Team Lead, Allston, Massachusetts in Allston, Massachusetts

This individual is responsible for providing leadership support within the department. The position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's.

Responsibilities include:

· Perform Water, Steam, and Critical Utility testing

  • Perform In Process sample testing for Bioburden and Endotoxin

  • Run daily staff MDI/shift handover meeting

  • Manage and coordinate studies and projects

  • Coordinate daily scheduling and assigments as necesary

· Act as the primary contact for the team interacting with various departments when supervisors are not present

· Represent the functional area in meetings and compliance activities

· Actively troubleshoots routine problems with equipment and methods

· Actively participate in manufacturing scheduling meetings

· Participate in both internal and external audits

· Perform and review assays as needed

· Author/Review technical documents/protocols

· Assist with interviewing and onboarding new hires

· Act as Document Owner for SOPs and maintain periodic reviews

· Actively supports the QC Management team

· Completes Trackwise Laboratory Investigations/Deviations/CAPA/Change Controls

· Ensures timely escalation of critical issues

· Maintains positive relationships and networks effectively across sites and

organizations

· Participates in training more junior employees

· Ensure all safety requirements are being met within the department including PPE

and waste disposal

· Facilitates operational excellence through continuous improvement initiatives

Basic Requirements:

Bachelor's Degree in a science or technical related field plus 4 years Quality and/or Operations experience in a CGMP

Manufacturing Environment

· Experience with scientific and technical writing

· Knowledge of CGMP regulations for US, EU and other regulatory agencies

· Strong computer, verbal, and written communication skills

· Strong technical writing skills

· Effective skills in time management, organization, teamwork, collaboration, and

leadership

· Attention to detail

· Trackwise or other investigation system experience

Preferred:

Masters' plus 1 year Leadership in a CGMP Quality and/or Operations experience

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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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

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