Senior QA Specialist; Qualified Treatment Centers
Listed on 2025-12-15
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Quality Assurance - QA/QC
Data Analyst
Kelly Science is seeking a Senior Quality Assurance Specialist/Quality Assurance Manager to join a growing team in Boston, MA for a long‑term contract.
Pay: $62‑72/hour depending on experience
Shift: Monday‑Friday 8am‑5pm
Employment Type:
Full Time; 12 month contract
Work Model:
Hybrid – 3 days on‑site, 2 days WFH
The Senior Quality Assurance Specialist/Quality Assurance Manager will oversee quality at the company’s Qualified Treatment Centers (QTCs) for commercial gene therapies. This key role involves building scalable QA processes to support company growth and working closely with Apheresis Operations, Global Supply Chain, and Quality Compliance. Responsibilities include managing Quality Agreements with QTCs, overseeing change controls for QTC onboarding, approving QTC‑related quality documentation, managing quality‑system record maintenance for apheresis product collection and transport, and monitoring QTC use of the company’s traceability systems.
Responsibilities- Ensure GTP, GMP, and GDocP compliance for apheresis products and the company’s QTCs.
- Build relationships with QTC QA partners, track quality issues, and collaborate with internal teams for resolution.
- Standardize quality approaches across all QTCs through Quality Agreements.
- Track and trend quality‑system events at QTCs, providing management updates.
- Review and approve documents such as collection records, deviations, and CAPAs.
- Approve internal deviations, CAPAs, and Change Controls; perform root‑cause analysis as needed.
- Develop and improve scalable and sustainable quality processes.
- Promote a risk‑based and innovative quality mindset throughout the company.
- Bachelor’s degree in a scientific related field.
- 7+ years of experience working within a cell therapy environment (hospital setting preferred).
- Strong knowledge of FACT accreditation requirements and its applications for apheresis and/or cell therapy labs, GTP regulations and guidance documents, and quality agreements strongly preferred.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work‑related resources. Eligible employees enjoy voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short‑term disability. Additional benefits include a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), a transit spending account, and paid sick leave under the applicable state or local plan.
EqualEmployment Opportunity
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce.
Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E‑Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S.
Interested? Please apply today for immediate consideration!
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