QA Operations Specialist – On-the-Floor cGMP Expert

Sanofi Group; Framingham (MA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health & wellness benefits

Parental leave (14 weeks)

Job summary

Sanofi is seeking a Quality Assurance Specialist to oversee quality activities at the Framingham, MA site. The role emphasizes supporting manufacturing and ensuring adherence to cGMP practices while mentoring junior staff.

You will perform batch record reviews, participate in audits, and drive continuous compliance across operations. A scientific degree with CGMP experience and strong communication skills are required.

Qualifications

• Bachelor’s degree in a scientific field and 4 years of related experience, or an equivalent combination of education and experience.
• Bachelor’s degree in a non-scientific field with 6 years of related experience in a CGMP environment.
• Strong verbal and written communication skills.
• Experience with quality systems and cGMP data review.

Responsibilities

• Provide Gemba support to manufacturing and support functions.
• Perform batch record review.
• Review 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 critical operation steps.
• Issue action notices and conduct provisional releases.
• Conduct log book audits to ensure compliance.
• Review CV-related documentation against specification.
• Perform media/buffer and intermediate release.
• Prepare Bioreactor summaries.
• Support internal audit preparation and cross-functional audits.
• Execute containment activities.
• Provide off-hour support for batch record and log book issuance.
• Partner with manufacturing to foster continuous compliance.
• May train new employees.
• Revise procedures/SOPs.
• Initiate, investigate and QA review deviations.
• Review NRSR (Non-Routine Sample Requests).
• Other activities as assigned.

Skills

Quality systems

cGMP data review

Verbal & written comms

Education

Bachelor’s degree in scientific field

Associate’s degree + 6 years experience

High School Diploma + 8 years experience

Bachelor’s degree in non-scientific field + 6 years experience

Job description

Sanofi is seeking a Quality Assurance Specialist to oversee quality activities at the Framingham, MA site. The role emphasizes supporting manufacturing and ensuring adherence to cGMP practices while mentoring junior staff.

You will perform batch record reviews, participate in audits, and drive continuous compliance across operations. A scientific degree with CGMP experience and strong communication skills are required.