Quality Compliance Specialist, Cellular Therapy

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 & 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 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 QA/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

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

         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.

SKILLS/ABILITIES/COMPETENCIES 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

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.