Quality Assurance Specialist

Regulatory Jobs; Framingham (MA); On-site; USD 69,000 - 100,000; Full time

Job summary

Sanofi is seeking a Quality Assurance Specialist in Framingham, MA to ensure continued cGMP compliance in manufacturing and support functions. You will mentor junior staff, provide on-the-floor support for critical steps, and review batch records to maintain product quality and safety.

Ideal candidates have a scientific degree with relevant cGMP experience, strong communication skills, and the ability to lead quality investigations and audits.

Qualifications

• Bachelor’s degree in a scientific field with 4 years of related experience or higher.
• Experience with quality systems and cGMP data review.
• Strong verbal and written communication skills.

Responsibilities

• Provide quality support to manufacturing and support functions to ensure cGMP compliance.
• Review batch records and related documentation for accuracy and completeness.
• Mentor junior staff and support internal audits and CAPA processes.
• Provide on-the-floor support for critical operations steps and issue action notices.
• Lead and participate in cross-functional quality investigations and deviations.

Skills

Quality systems

cGMP data review

Communication skills

Computer proficiency

Education

Bachelor’s degree in a scientific field

Bachelor’s degree in a non-scientific field with 6 years related experience

Job description

Job Title: Quality Assurance Specialist

• Location: Framingham, MA

About the Job

Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi's Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets. 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.

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 lives.

Main Responsibilities

The Quality Assurance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Quality Assurance Specialist is also responsible for mentoring and supporting the junior staff.

• Provide Gemba Support
• Perform batch record review
• Perform review of column packing and qualification records
• Function as SME on input related to quality decisions
• Approve Non-conforming material discards
• Perform log book review
• Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps
• Issue action notices and conduct affiliated provisional release
• Conduct log book audits against compliance requirements
• Review Cleaning Verification (CV) related documentation against specification
• Perform media / buffer and intermediate release
• Prepare Bioreactor summary
• Support internal audit preparation activities as well as cross-functional internal audit activities and conduct walkthrough inspections
• Execute containment activities
• Provide off-hour support for batch record and log book issuance
• Partner with manufacturing and support operations to ensure a culture of continuous compliance
• May provide training to new employees
• Revise procedures / SOPs
• Initiate and Investigate and QA review deviations
• Review NRSR (Non-Routine Sample Requests)
• Other activities as assigned

* Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

Leadership Qualifications

An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services. This includes:

• Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
• Being honest and treating people with respect and courtesy.
• Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.
• Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.

About You

Basic Qualifications

• Bachelor’s Degree in a scientific field and 4 years of related experience, associate’s degree and 6 years of related experience or High School Diploma and 8 years of related experience in a Quality and /or other CGMP related field.
• Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and / or cGMP environment.
• Basic to Intermediate computer proficiency, strong verbal and written communication skills.
• Experience with quality systems and cGMP data review

Preferred Qualifications

• Bachelor’s degree in a scientific field with 4 years of experience in a Quality and / or cGMP environment.
• Experience in bio-pharmaceutical industry.
• Strong technical writing skills
• Effective time management, attention to detail, organizational skills, teamwork and collaborations.
• Demonstrated competence in problem solving methodology.
• Experience participating and/or leading cross-functional project team collaborations.

Special Working Conditions

• Ability to gown and gain entry to manufacturing areas
• Ability to work a 10-hour shift with rotating weekend coverage, including some holidays
• Ability to lift 10 lbs

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.
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

The salary range for this position is:

$69,000.00 - $99,666.66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.