Bone Marrow Transplant Compliance Specialist
Massachusetts General Hospital(MGH)

Boston, Massachusetts

Posted in Health and Safety


Job Info


GENERAL SUMMARY

The Hematopoietic Cell Transplant and Cellular Therapy (HCTCT) Quality Assurance and Compliance 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. These positions are responsible for the Cellular Therapeutics and Transplantation Laboratory (CTTL) quality assurance goals and quality improvement activities in the context of both standard of care and clinical research guidance. These positions also collaborate with the Laboratory Medical Director, Cellular Immunotherapy Administrative Director, HCTCT Quality Manager, Laboratory Technical Specialists as well as other institutional departments and outside facilities that play a role in cellular therapies.

The compliance and assurance roles have distinct responsibilities with occasional overlap. Candidates are hired and assigned to either the Hematopoietic Cell Transplant or the Cellular Therapy service based on program needs.

PRINCIPAL DUTIES AND RESPONSIBILITIES

COMPLIANCE ROLE:

  • Ensure compliance with all applicable state and federal regulations and with FACT, JC, and other accreditation standards as applicable
  • Conduct quality system audits identifying areas of non-compliance and risk
  • 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 notification of non-conforming forms
  • Perform regularly scheduled audits as required by FACT standards
  • Work collaboratively with the Technical Specialist to maintain and update the laboratory Quality Management Plan to remain in compliance with FACT and regulatory standards
  • Review new or revised standard operating procedures, 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 validation plan(s) and completed validations including those for equipment and procedures
  • Complete investigations of occurrence reports
  • Review and approve CAP survey results
  • Periodic reviews of contracts with critical suppliers
QUALITY ASSURANCE ROLE:
  • Prepare quality management reports and annual summaries for BMT and Cellular Therapy Programs
  • Perform risk assessment/change control
  • Work with the Technical Specialist to prepare monthly QM reports encompassing all areas of the program to identify problems, trends, and CAPA and make them available to staff for review and comment
  • Perform quarterly review of safety/incident reports to identify trends and apply corrective action when a deviation has been identified
  • Perform monthly QC record review
  • Review engraftment data in conjunction with the BMT Clinical Quality Manager and perform CTTL investigations regarding failure or delay when warranted
  • Conduct RCA as needed for significant events
  • Responsible for monthly and quarterly reporting of total bone marrow harvests, non-conforming products, contaminants, accidents, errors, and complaints.
  • Collaborate with key stakeholders on corrective action plans. Evaluates corrective action plans
  • Plan project specific audits and follow up activities for assigned projects
  • In compliance with FACT standards, work with the BMT Quality Project Manager to facilitate the administrative responsibilities of the monthly BMT Quality meeting
  • Review monthly and annual audit summaries of processing laboratory and apheresis unit
  • Perform audits of new vendors and periodically review historical vendors to determine vendor compliance with current laws, accreditation requirements and suitability
COMBINED DUTIES - APPLIES TO BOTH ROLES:
  • Work in partnership with the BMT Quality Project Manager on the Quality Management Plan as it relates to the laboratory and initiate audits per CTTL needs
  • Independently conduct audits of complex data and documents. Prepare reports following established protocols and methods based on audit findings
  • Develop audits to track and trend for errors/accidents/deviations and to meet regulatory and accreditation requirements
  • Manage and participate in process improvement projects
  • Coordinate correspondence with outside agencies and accrediting bodies
  • Collaborate with members of the team to develop and implement new cell processing methods
  • 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 and AABB
  • 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 laboratory leadership.
ADDITIONAL DUTIES ASSIGNED TO QUALITY ASSURANCE/COMPLIANCE ROLES FOR CELLULAR THERAPY ONLY
  • Periodic review of QA agreements for both standard of care and research
  • Review of job aids and product manuals to ensure compliance with FACT and FDA regulations
  • Perform internal audits on clinical trial study binders
  • Review study site initiation forms and participate in site initiation visits (SIV)
  • Report adverse events to sponsors when applicable
  • Prepare for sponsor initiated external audits
  • Provide complete investigational reports to study sponsors when requested
WORKING CONDITIONS

  • Majority of time spent in an office environment working at a computer.
  • Hybrid position (on site and remote).
  • Work may require standing and walking during observation of clinical practices.
  • Potential exposure to biological hazards normally associated with a clinical patient area and processing laboratory


Qualifications
SKILLS / ABILITIES / COMPENTENCIES REQUIRED
  • Displays advanced knowledge of all applicable regulations and QA concepts and practice
  • Recognized as a quality 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
  • Familiar with federal, state, and local regulations, FACT, AABB, FDA and JC accreditation requirements
QUALIFICATIONS

Required:
  • Bachelor of Science in medical technology, biological science, or a related field with a minimum of 3 years of experience.
  • 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 HPC collection, processing, infusion, and/or patient management
  • Experience in quality management


EEO Statement
MassachusettsGeneral Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, wechoose to lead. Applications from protected veterans and individuals withdisabilities are strongly encouraged.



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