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Quality Assurance Specialist, Cellular Therapy

Massachusetts General Hospital
United States, Massachusetts, Boston
75 Blossom Court (Show on map)
May 14, 2025
GENERAL SUMMARY/ OVERVIEW STATEMENT: The Hematopoietic Cell Transplant and Cellular Therapy (HCTCT) Quality Assurance Specialists are responsible for performing a wide variety of activities to ensure compliance with federal, state, and local regulations, FACT/JC/FDA and other accreditation standards and institutional requirements. The Cellular Therapy Quality Assurance role is responsible for the Cellular Therapeutics and Transplantation Laboratory (CTTL) quality assurance goals and quality improvement activities in the context of Cellular Therapy (which entails both standard of care and clinical research). These roles also collaborate with the Medical Director, Laboratory Director, HCTCT Clinical Quality Team, Laboratory Research Team, Laboratory Management as well as other institutional departments and outside facilities that play a role in cellular therapies. The Cellular Therapy Quality Assurance Specialists as well as the Hematopoietic Cell Transplant Quality Assurance Specialists may work collaboratively to fulfill program needs. PRINCIPAL DUTIES AND RESPONSIBILITIES: RESPONIBILITIES: 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 Management 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 Cellular Therapy Amendments, Note to Files, Memos, etc. Review and approve validation plan(s) and completed validations including those for equipment and procedures as applicable Cellular Therapy Review CTTL staff's training and competencies Performs review and investigation of 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 Cellular Therapy 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 a focus on Cellular Therapy to identify problems, trends, and CAPA and make them available to staff for review and comment Perform quarterly review of Cellular Therapy safety/incident reports to identify trends and apply corrective action when a deviation has been identified Responsible for monthly and quarterly reporting of total Cellular Therapy 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 Cellular Therapy QA agreements ADDITIONAL RESPONSIBILITES: 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 Actively participate in the development of quality standards and quality management Educate and inform staff about quality standards and new and existing regulations 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 Collaborates with leadership in identification of current and future service needs and shares responsibility for meeting those needs Performs other duties as assigned by program and leadership *QUALIFICATIONS:* Required: Bachelor of Science in medical technology, biological science, or a related field with a minimum of 3 years of experience -or- 8 years of relevant experience At least 3 years professional experience in Quality Assurance Certification in Quality (NAHQ, ASQ or equivalent) and/or 3 years professional experience within the field of Cellular Therapy 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 Preferred: Experience in Cellular Product collection, processing, infusion, and/or patient management Experience in quality management. Certification in Quality (NAHQ, ASQ or equivalent) and/or 3 years professional experience within the field of Cellular Therapy *SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:* 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 *WORKING CONDITIONS:* Describe the conditions in which the work is performed. Hybrid position (on site and remote). Work may require standing and walking during observation of clinical practices and sitting/standing at a computer. Potential exposure to biological hazards normally associated with a clinical patient area and processing laboratory. The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.