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Sanofi Group Quality Control Team Lead in Framingham, Massachusetts

Shift Schedule:

2nd Shift, Sunday through Wednesday, 12:00pm to 10:30pm

Location:

Framingham, MA

Department Description:

Quality Control Microbiology supports manufacturing activities at Genzyme's Framingham Campus by detecting, quantifying, and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility Systems and within the environmental where the manufacturing process is executed. It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the end product will meet the pre-defined standards for safety, purity, identity and effectiveness.

Position Summary:

Contribute to general operations and testing of the QC Microbiology laboratory. The Quality Control Team Lead works independently to collect and process samples in a timely manner and routinely assumes a leadership role to perform microbiological testing and/or validation in accordance with SOP’s and cGMP regulations, review laboratory assay documentation for accuracy and timeliness, participate with the team to meet the group goals, employ in-depth technical knowledge and define, strategize and implement laboratory studies.

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

  • Participate in both internal and external audits

  • Coordinate daily scheduling and assignments

  • Perform and review routine lab assays such as:

  • Biological Indicator Testing.

  • ELISA testing.

  • Endotoxin Testing (Gel Clot and Kinetic Turbidimetric).

  • Bioburden Testing of In-Process products, buffers, and water.

  • TOC Testing

  • Conductivity Testing

  • Receive manufacturing samples into the QC Lab as well as sample retain disposal.

  • Author/Review technical documents/protocols

  • Assist with interviewing and onboarding new hires

  • Act as Document Owner for SOPs and maintain periodic reviews

  • Run staff daily QDCI/DCM Meetings

  • Actively supports the QC Management team

  • Completes Phenix 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

  • Participate in authoring complex and explicit documentation (protocols and technical reports)

  • Involvement in equipment or facility qualifications (IQ/OQ/PQ) and method validation

  • Represent QC in internal and external audits as required

  • Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs

Basic Qualifications:

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

Preferred Qualifications:

  • Knowledge 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

Special Working Conditions:

  • Must be able to lift 40lbs.

  • Must be able to gown and gain entry into manufacturing areas

  • Nights, weekends and holidays may be required

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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