Sanofi · 2 days ago
Quality Assurance Specialist
Pearl River, NY
Full-time
Onsite
Entry, Mid Level
$69K/yr - $100K/yr
2+ years expSanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. The Quality Assurance Specialist will provide direct quality support to ensure compliance with manufacturing activities, conduct audits, and manage quality-related issues effectively.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
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)
Qualification
Required
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
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-08
Company data provided by crunchbase