Job Title: USA-Quality Assurance Associate II (Clinical)
Duration: 12 Months Contract
Location: Framingham, MA (Hybrid)
Job Highlights:
- 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).