Quality Assurance Specialist

About the role

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing treatments reach people everywhere, faster.

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

Key roles (D,A,I)

• 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)

Requirements

• 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.
• Knowledge of large-scale bioreactor technology.
• Proficiency in Power BI and AI applications, and a willingness to adopt emerging technologies.

Qualifications

• Minimum 2 years of quality assurance experience with a bachelor's degree, or 3+ years with an associate degree.
• 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.
• Knowledge of large-scale bioreactor technology.
• Proficiency in Power BI and AI applications, and a willingness to adopt emerging technologies.

Skills

• 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.
• Knowledge of large-scale bioreactor technology.
• Proficiency in Power BI and AI applications, and a willingness to adopt emerging technologies.

Benefits

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

Pay

Compensation will be determined commensurate with demonstrated experience.

Schedule

Full time