Contamination Control SME & CAPA Lead

Sanofi Group

Framingham (MA)

On-site

USD 80,000 - 120,000

Full time

9 days ago

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Job summary

Sanofi Framingham Biologics Campus is seeking a Contamination Control Specialist to join the Sterility Assurance and Microbiology team. You will apply microbiological control principles to maintain environmental control and support manufacturing quality on the shop floor.

The role focuses on leading risk assessments, investigations of contamination events, and CAPA development in collaboration with cross-functional teams to ensure product quality and compliance.

Responsibilities

  • Leading as SME specific subjects part of the Contamination Control SOP in her/his area of expertise
  • Conducting risk assessments related to contamination control
  • Overseeing sites activities and performance for contamination control systems in her/his scope of responsibilities
  • Leading investigation following contamination control failures and proposing corrective and preventive actions (CAPA)
  • Collaborating with cross-functional teams to ensure product quality
  • Ensuring presence on the shop floor to oversee practices, identify

Job description

Sanofi Framingham Biologics Campus is seeking a Contamination Control Specialist to join the Sterility Assurance and Microbiology team. You will apply microbiological control principles to maintain environmental control and support manufacturing quality on the shop floor.

The role focuses on leading risk assessments, investigations of contamination events, and CAPA development in collaboration with cross-functional teams to ensure product quality and compliance.

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