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Sanofi Group Quality Control, Senior Team Lead in Framingham, Massachusetts

Shift Schedule: Sunday through Wednesday, 2nd Shift (Noon-10:30pm)

Quality Control (QC) is responsible for testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls. Quality Control Validation Support consists of the Method Validation Group and the Equipment Qualification Group. Quality Control is also responsible for assisting in site-wide studies and projects.

Position Overview with Key Responsibilities:

  • 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:

  • Provide motivation, inspiration, and feedback to staff under general supervision. Manage and coordinate studies and projects

  • Act as the primary contact for the team interacting with various departments

  • 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

  • Coordinate daily scheduling and assignments as necessary

  • 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

  • Run daily staff QDCI/DCM meetings

  • 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 QUALIFICATIONS:

  • Bachelor's Degree and 6 years Quality and/or Operations experience in a CGMP Laboratory Environment or Masters Degree in Life Science and 4 years Quality and/or Operations experience in a CGMP Laboratory Environment

PREFERRED QUALIFICATIONS:

  • Bachelor's Degree in a science or technical related field

  • Knowledge Experience with scientific and technical writing 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

Special Working Conditions:

  • Ability to lift up to 10lbs

  • Ability to enter Quality Control laboratories

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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