The Quality Assurance Specialist is 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. This position is 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. This position will also collaborate with the Laboratory Medical Director, Cellular Immunotherapy Administrative Director, BMT Quality Manager, Laboratory Technical Specialist as well as other institutional departments and outside facilities that play a role in cellular therapies.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1. 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
Coordinate, compile and submit requested documentation in preparation for FACT accreditation inspection, follow-up, and yearly summary reports
Coordinate correspondence with outside agencies and accrediting bodies
Review and assist with completion of Requests for Information (RFI)
Collaborate with members of the team to develop and implement new cell processing methods
2. Work partnership with the BMT Quality Project Manager on the Quality Management Plan as it relates to the laboratory and initiate audits per CTTL needs.
Develop audits to track and trend for errors/accidents/deviations and to meet regulatory and accreditation requirements
Perform regularly scheduled audits as required by FACT standards
Review, approve and follow-up of corrective/preventative actions when a deviation has been identified
In compliance with FACT standards, work with the BMT Quality Project Manager to facilitate the administrative responsibilities of the monthly BMT Quality meeting
Work collaboratively with the Technical Specialist to maintain and update the laboratory Quality Management Plan to remain in compliance with FACT and regulatory standards
3. Prepare quality management reports for BMT and Cellular Therapy Programs
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
Independently conduct audits of complex data and documents. Prepare reports following established protocols and methods based on audit findings.
Review safety/incident reports and deviations. Conduct RCA as needed for significant events. Collaborate with key stakeholders on corrective action plans. Evaluates corrective action plans.
Plan project specific audits and follow up activities for assigned projects
Review monthly and annual audit summaries of processing laboratory and apheresis unit.
4. Review new and revised policies and standard operating procedures to ensure compliance with FDA regulations and FACT requirements. Approve policies and procedures for the processing laboratory and clinical program
Review and approve validation plans and completed validations including those for equipment and procedures
Perform audits of new vendors and periodically review historical vendors to determine vendor compliance with current laws, accreditation requirements and suitability
5. 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 credits per FACT standards
6. Performs other duties as assigned by Program Leadership and in collaboration with Laboratory Leadership
Bachelor of Science in medical technology, biological science, or a related field with a minimum of 5 years of experience.
Certification in Quality (NAHQ, ASQ or equivalent) and/or 5 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
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 in 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
Majority of time spent in an office environment working at a computer
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
Internal Number: 3131605
About Mass General Hospital
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