Mass General Brigham · 1 day ago
Quality Assurance Specialist, Cellular Therapeutics
Boston, MA
Full-time
Hybrid
Mid Level
$80K/yr - $116K/yr
3+ years expMass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service. They are seeking a Quality Assurance Specialist to ensure compliance with various regulations and accreditation standards within the Cellular Therapeutics and Transplantation Laboratory, while collaborating with multiple teams to fulfill program needs.
Health CareHome Health CareMedical
Responsibilities
Perform FACT self-assessment as well as coordinate, compile and submit requested documentation in preparation for the FACT accreditation inspection and follow-up on any citations or findings post inspection
Review and assist with completion of Requests for Information (RFI)
Review of non-conforming forms
Work collaboratively with Laboratory leadership to maintain and update the laboratory Quality Management Plan to remain in compliance with FACT and regulatory standards
Review new or revised internal standard operating procedures, job aides, worksheets, and forms to ensure compliance with FDA regulations and FACT requirements. Approve policies and procedures for the processing laboratory and clinical program
Review and approve new or revised Cellular Therapy product manuals, protocols, and forms (provided by sponsor/manufacturer) and ensure compliance with FDA regulations and FACT requirements
Review and approve investigational Cellular Therapy related protocol amendments, Note-to-File, Memos, etc
Review and approve validation plan(s) and completed validations including those for equipment and procedures
Review CTTL staff’s training and competencies
Review and investigate occurrence/safety/incident reports and conducts RCA/CAPAs as needed
Participate in site initiation visits (SIV) and collaborate with Research Team on research study site initiation forms, when needed
Provide complete investigational reports, Note to Files or Memos to sponsors/manufacturers when requested
Develop and conduct internal audits of complex data and documents. Prepare reports following established protocols and methods based on audit findings
Prepare quality management reports and annual summaries for the HCTCT Program
Work with Laboratory Management to prepare monthly QM reports with to identify problems, trends, and CAPA and make them available to staff for review and comment
Perform quarterly review of HCTCT safety/incident reports to identify trends and apply corrective action when a deviation has been identified
Responsible for monthly and quarterly reporting of total bone marrow harvests, non-conforming products, contaminants, accidents, errors, and complaints
In compliance with FACT standards, work with the HCTCT Clinical Quality Team to facilitate the administrative responsibilities of the monthly HCTCT Quality meeting
Initial and periodic review of QA agreements for Research & Standard-of-Care products
Actively participates in the development of process improvement projects including but not limited to in collaboration with Laboratory Management and/or the Research Team
Collaborate with members of the team to develop and implement new workflows
Participate in standard development activities in the field of cellular therapy through committee membership and interaction with professional organizations such as FACT
Attend and participate in professional educational activities in the fields of quality and cellular therapies and serve as a ‘subject matter’ expert
Maintain appropriate continuing education hours per FACT standards
Qualification
Required
Bachelor's degree required
3 years of experience in a healthcare setting required
Must be knowledgeable of FDA (GMP/GTP regulations), CLIA, OSHA, and DPH regulations as well as FACT, JC, and AABB accreditation standards
Proficiency in the use of computers and Microsoft Office
Proven coordination, team, leadership, and service skills
Displays advanced knowledge of all applicable regulations and QA concepts and practice
Recognized as a quality compliance/assurance resource within own department
Demonstrates effective, self-sufficient communication skills, including peer-directed presentations
Demonstrates ability to plan and execute appropriate test systems and validations
Has ability to lead process improvement projects of moderate complexity and scope
Preferred
3 years professional experience in Quality Assurance preferred
Certification in Quality (NAHQ, ASQ or equivalent) and/or 3 years professional experience within the field of Hematopoietic Cell Transplant and Cellular Therapy preferred
Benefits
Comprehensive benefits
Career advancement opportunities
Differentials
Premiums
Bonuses
Recognition programs designed to celebrate your contributions and support your professional growth
Company
Mass General Brigham
Mass General Brigham specializes in providing medical treatments and health diagnostics services.
10001+ employees
H1B Sponsorship
Mass General Brigham has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (77)
2024 (61)
2023 (93)
2022 (70)
2021 (80)
2020 (29)
Funding
Current Stage
Late StageLeadership Team
E
Erin Flanigan
SVP, Human Resources, Community, Specialty Hospital Division
O’Neil A. Britton
Chief Integration Officer, Executive Vice President
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