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Quality Control Team Lead

Framingham, Massachusetts

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Responsibilities

**1st shift position- Monday-Friday with flexibility to work 4 x 10 hour shifts**

Department Description:

Quality Control (QC) is responsible for testing immediate production samples, finished product samples, stability samples, and environmental samples to demonstrate that all products meet the standard requirements for cGMP operations. The QC Sample Management Team supports the QC Chemistry, QC Microbiology, and QC Biosurgery laboratories at the Framingham, MA manufacturing site.

Key Responsibilities:

  • Provide motivation, inspiration, and feedback to staff under general supervision
  • Act as the primary contact for the team interacting with various departments
  • Represent the Sample Management Team in meetings and compliance activities
  • Actively troubleshoots and remediates routine problems
  • Participate in both internal and external audits
  • Coordinate daily scheduling and assignments for the Sample Management Team
  • Assist with interviewing, onboarding, and training of new hires
  • Act as Document owner for area SOPs, and maintain periodic reviews
  • Runs staff daily +QDCI/DCM meetings
  • Actively supports the QC Management Team
  • Ensure timely escalation of critical issues
  • Maintain positive relationships and networks effectively across sites and organizations
  • Participate in training of more junior employees
  • Ensure all safety requirements are being met within the department including PPE and waste disposal
  • Facilitate operational excellence through continuous improvement initiatives
  • Oversee maintenance of logbooks used in QC
  • Perform and oversee sample receipt and sample disposal in QC
  • Ensure maintenance and organization of Cold Room and Freezer areas
  • Coordinate distribution of samples to other laboratories
  • Perform Sample Pick ups around site as needed
  • Order and receive laboratory supplies for multiple QC labs
  • Archive records and logbooks
  • Manage laboratory reserve/retain samples
  • Assist Management/Lab personnel with basic laboratory activities
  • Clean and properly store Laboratory Glassware

Basic Qualifications:

  • HS/GED with 7 years' experience in Quality and/or Operations experience in a cGMP environment--OR--Bachelor's Degree and 4 years Quality and/or Operations experience in a cGMP environment

Preferred Qualifications:

  • Knowledge of cGMP regulations for US, EU and other regulatory agencies
  • Attention to Detail
  • Strong computer, verbal, and written communication skills
  • Effective skills in time management, organization, teamwork, collaboration, and leadership
  • Experience using SmartQC, iLIMS or BioLIMS data management systems.

Special Working Conditions:

  • Must be able to lift 40lbs
  • Ability to enter Quality Control Laboratories
  • Position is considered on site essential personnel and may be required to work during inclement weather events.

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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