Quality Assurance Specialist

Sanofi • Framingham, MA

4d • Onsite

About The Position

Quality Assurance Operations provides quality oversight of operations at Sanofi’s Framingham Biologics facilities, ensuring cGMP compliance during manufacturing. The Quality Assurance Specialist provides quality support and guidance to manufacturing and support functions to protect product safety, quality, and efficacy and help ensure compliant products are available to patients. The role also mentors and supports junior staff.

The position supports manufacturing and quality-system activities, including batch and logbook reviews, on-the-floor support, documentation review, deviation investigation, release activities, audit preparation, containment, and procedure revision. The role may also train new employees and provide off-hour support for batch record and logbook issuance. Key responsibilities may vary or change in accordance with business needs.

The role requires the ability to gown and enter manufacturing areas, work 10-hour shifts with rotating weekend coverage and some holidays, and lift 10 pounds. Sanofi describes its work as part of a global Manufacturing & Supply organization focused on delivering treatments and vaccines. The company also highlights opportunities for career growth and a rewards package with health and wellbeing benefits, including at least 14 weeks of gender-neutral parental leave.

Requirements

• Bachelor’s degree in a scientific field and 4 years of related experience; or 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.
• Alternatively, a bachelor’s degree in a non-scientific field and 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.
• 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 pounds.

Nice To Haves

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

Responsibilities

• Provide Gemba support.
• Perform batch record reviews.
• Review column packing and qualification records.
• Serve as a subject matter expert on input related to quality decisions.
• Approve non-conforming material discards.
• Review logbooks and conduct logbook audits against compliance requirements.
• Provide on-the-floor support to operations, including support for critical operational steps.
• Issue action notices and conduct affiliated provisional release.
• Review Cleaning Verification documentation against specifications.
• Perform media, buffer, and intermediate release activities.
• Prepare bioreactor summaries.
• Support internal audit preparation and cross-functional internal audit activities; conduct walkthrough inspections.
• Execute containment activities.
• Provide off-hour support for batch record and logbook issuance.
• Partner with manufacturing and support operations to promote a culture of continuous compliance.
• May provide training to new employees.
• Revise procedures and SOPs.
• Initiate and investigate deviations and perform QA review of deviations.
• Review Non-Routine Sample Requests (NRSR).
• Mentor and support junior staff.
• Perform other activities as assigned.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employees may be eligible to participate in company employee benefit programs.
• Rewards package recognizing employee contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level