USA-Quality Assurance Associate II (Clinical) in

  • Title: USA-Quality Assurance Associate II (Clinical)
  • Code: RCI-9324
  • RequirementID: 53651
  • Location:
  • Posted Date: 12/06/2024
  • Duration: 12 Months
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  Job Description

Hybrid Role • Support timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) and ensure alignment with quality and regulatory expectations prior to release and/or approval. • Maintain organization of project deliverables for external partner project using applicable tools. • Identify and communicate quality risks in a pro-active and collaborative manner maintaining the business interests of Sanofi and consideration of suitable outcome for the projects. • Participate in and support batch associated deviations, risk assessments, and change controls in compliance with SOPs and company policies. • Develop trusting team partnerships to ensure highly collaborative project outcomes. • Act as Quality Focal Point to represent site on CMC Quality sub-team(s) for assigned project(s). Years Experience: 3-6 years Minimum Education: Bachelor's Degree in Science related field.

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