Cell Therapy Manufacturing – Quality Assurance Specialist (IS​/Quality Systems Validation

Must have a working knowledgeable of basic and complex principles and practices of cell processing and experience as an auditor and compliance specialist. The QA/QI Specialist is responsible assisting in the monitoring for quality to ensure that systems are appropriate, current and being adhered to by all staff of the Cell Manipulation Core Facility. This position requires the individual to be actively engaged in the field by teaching, managing and advancing the field by participation in professional meetings, publications or presentations.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations.

We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

• Be knowledgeable with all requirements of regulatory and accreditation agencies to include: FACT, FDA, JCAHO, AABB, CLIA, DOT, DPH and OSHA
• Perform and report on internal audits and assessments of laboratory processes to ensure compliance with JCAHO, AABB and FACT standards and FDA regulations and outside sponsor audits
• Responsible to work with the manager to update the Quality Program for hematopoietic progenitor cells, therapeutic cells and other cell processing according to regulatory and accrediting organization requirements
• Assist QA Manager in interactions with industry and government to include IND submissions, FDA registration or licensure, etc.
• Prepare and participate in inspections and compliance audits
• Leading and facilitating various quality processes (RCA, CAPA, Lean, and FMEA) to improve the department and report on laboratory’s performance. Participate in continuous improvement activities
• Manager the laboratory Episode/Deviation Log, track and analyze deviations for undesirable trends and propose methods of quality improvement. This includes reporting on errors, deviations, OOS (out of specifications) and adverse events and working with various teams to propose improvement opportunities
• Manage and report data for evaluation of clinical outcomes to include reviewing, compiling, and performing trend analysis of engraftment, bone marrow harvest quality and infusional toxicities data
• Review manufacturing and quality control records. Document deviations / omissions and initiate corrective action and documentation of these actions
• Manage periodic review of assigned laboratory manuals, maintenance of archive files and maintenance of files of any other pertinent documentation for new or revised policies and procedures
• Manage continuing education program for laboratory personnel on relevant aspects of CMCF policies, procedures and the Quality Program.
• Assist in development of policies and procedures for product testing and release and perform such testing. Provide training on procedures for CMCF laboratory personnel
• Development training modules and provide training in areas of subject matter expertise
• Work within the cGMP and cGTP guidelines and adheres to all regulatory standards within the Cell Manipulation Core Facility. Prepares and implement modules for GMP /GTP training
• Train CMCF members and others on safety program and clean room procedures well as emergency preparedness, chemical, infectious agents and radioactive hazards
• Maintain the continuing education records for laboratory employees.
• Verify that staff members adhere to department and section procedures and processes
• Assist in the development, implementation, monitoring of databases (engraftment, reactions, BOE, etc.) and information systems used in the department. Recommend audits for assessing performance of said databases
• Performs other duties as assigned
• Perform pre and post processing review of batch records to…