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
Summary:
The Senior Quality Assurance Specialist/Quality Assurance Manager will oversee quality at the companies Qualified Treatment Centers (QTCs) for commercial gene therapies. This key role involves building scalable QA processes to support company growth, working closely with Apheresis Operations, Global Supply Chain, and Quality Compliance. Key responsibilities include managing Quality Agreements with QTCs, overseeing change controls for QTC onboarding, and approving QTC-related quality documentation. This role also supports quality system record management for apheresis product collection and transport, plus overseeing QTC use of the companies traceability systems.
Job duties include:
+ Ensure GTP, GMP, and GDocP compliance for apheresis products and the companies 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 (e.g., collection records, deviations, CAPAs).
+ Review/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.
Qualifications:
+ Bachelors 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 collection of apheresis and or cell therapy labs, GTP regulations and guidance documents and quality agreements strongly preferred.
Interested? Please apply today for immediate consideration!
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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.