Quality Assurance Specialist

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* Job Title:

** Quality Assurance Specialist
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* Location:

** Framingham, MA
** 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.
** Monday-Friday, day shift.
**** 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:

*** Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
* 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
** Section 3:
Key involvement in Decision Making process
**** 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
**** Requirements/Qualifications
**** Expected Experience
*** BS – Life Sciences or related discipline is preferred but a combination of education and experience will be considered.
* Minimum of 2 years of experience in quality assurance within the pharmaceutical industry
* Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
** Expected Technical skills
*** Ability to analyze complex data and identify trends, issues, and solutions
* High level of accuracy and attention to detail in all quality assurance activities
* Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
* Proficiency in identifying problems and implementing effective corrective actions
* Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
** 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…