QA Operations Specialist: On‑Floor cGMP Support

Regulatory Toolkit; 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

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.