Quality Assurance Specialist
About The Position
Quality Assurance Operations provides quality oversight for operations at Sanofi’s Framingham Biologics facilities. The team ensures that cGMP requirements are followed during manufacturing and provides support and guidance to Operations to protect the safety, quality, and efficacy of Sanofi products, maintain compliant product availability, and safeguard the company’s business and global markets. The Quality Assurance Specialist supports and guides manufacturing and support functions to maintain cGMP compliance and mentors and supports junior staff. The role includes floor-based operational support, documentation and batch record review, quality decisions, release activities, audit support, deviation investigation, and collaboration with manufacturing and support operations to foster continuous compliance. Responsibilities may vary by employee and change according to business needs.
Requirements
- A bachelor’s degree in a scientific field and 4 years of related experience; an associate’s degree and 6 years of related experience; or a 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, organizational skills, teamwork, and collaboration.
- Demonstrated competence in problem-solving methodology.
- Experience participating in and/or leading cross-functional project team collaborations.
Responsibilities
- Provide Gemba support.
- Perform batch record review.
- Review column packing and qualification records.
- Serve as a subject matter expert for input related to quality decisions.
- Approve non-conforming material discards.
- Perform log book reviews and 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.
- Prepare bioreactor summaries.
- Support internal audit preparation and 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 promote a culture of continuous compliance.
- Mentor and support junior staff and may train new employees.
- Revise procedures and SOPs.
- Initiate and investigate deviations and conduct QA review of deviations.
- Review Non-Routine Sample Requests (NRSRs).
- 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.
- Opportunities for career growth through promotion or lateral moves, domestically or internationally.
- A rewards package that recognizes employee contributions.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
