Quality Assurance Specialist

Location: Pearl River

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* Job Title:

** Quality Assurance Specialist

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* Location:

** Pearl River, NY

** About the Job*
* 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.

** About Sanofi:*
* We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

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* Main Responsibilities:

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* + 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)

** About You*
* + 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

** Why Choose Us*
* + Bring the miracles of science to life alongside a supportive, future-focused team.

+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.

+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

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.

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** Pursue*
* ** _progress_**  **, discover*
* ** _extraordinary_*
* Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour,…