Quality Assurance Specialist

Responsibilities

• Provide direct shop floor quality support to ensure manufacturing activities comply with effective SOPs and SWIs
• Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulations
• Conduct regular audits of production processes to identify and address potential quality issues
• Collaborate closely with production teams to maintain quality standards throughout the product lifecycle
• Manage and resolve quality-related issues, including leading root cause analysis investigations
• Monitor and analyze quality performance metrics and implement corrective/preventive actions
• Participate in internal and external audits and regulatory inspections
• Develop and implement risk management strategies to mitigate potential quality issues

Requirements

• Bachelor's degree with minimum 2 years of quality assurance experience, OR an 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, and develop effective solutions
• Proficiency in large-scale single-use bioreactor technology
• Proficiency in Power BI and AI applications
• High level of accuracy and meticulous attention to detail

Benefits

• Thoughtful, well-crafted rewards package
• Wide range of health and wellbeing benefits, including high-quality healthcare
• Prevention and wellness programs
• At least 14 weeks of gender-neutral parental leave
• Opportunities for career growth through promotions or lateral moves

About the Company

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. We use our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world. Our state-of-the-art facilities and cutting-edge automation are redefining how life-changing treatments reach patients faster, safer, and more sustainably.