Quality Assurance Specialist

Quality Assurance Specialist – Pearl River, NY

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life‑changing treatments reach people everywhere, faster.

• Provide direct shop floor quality support to ensure manufacturing activities are performed in compliance with effective SOPs & SWIs.
• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
• Conducting regular audits of production processes to identify and address potential quality issues.
• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor.
• Managing and resolving quality‑related issues in a timely and effective manner.
• Monitoring and analyzing quality performance metrics, implementing corrective actions as needed.
• Leading root‑cause analysis investigations for quality incidents and implementing preventive measures.
• Participating in internal and external audits and regulatory inspections providing support and documentation.
• Developing and implementing risk‑management strategies to mitigate potential quality issues.
• Fostering a culture of quality and continuous improvement across the organization.

• Request corrections when GMP rules are not respected (D).
• Prioritize quality and compliance objectives (A).
• Proactively implement remediation action from findings from internal and external audits related to quality issues (D).
• Request quality improvement initiatives and strategies (D).
• Identify discrepancies and corrective/preventive actions that need to be taken (D).
• Escalate to upper management any failure in GMP execution on shopfloor (I).
• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures (I).
• Advise on how to present a topic and answer specific questions (A).
• Advise on risk management strategies and plans (A).
• Advise on initiatives to promote a quality‑focused culture (A).

• Bachelor's degree with minimum 2 years of quality assurance experience, OR associate degree with 3+ years of quality assurance experience.
• Comprehensive knowledge of Good Manufacturing Practices (GMP) and quality assurance principles.
• Proven ability to analyze complex data sets, identify trends, detect issues, and develop effective solutions.
• Demonstrated high level of accuracy and meticulous attention to detail in all quality assurance activities.
• Expertise in identifying quality issues and implementing effective corrective and preventive action.
• Proficiency in large scale single‑use bioreactor technology.
• Proficiency in Power BI and AI applications, and a willingness to adopt emerging technologies.

$69,000.00 – $99,666.66

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiant 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 refusal to submit to genetic testing) or any other characteristic protected by law.