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

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.

About the role

The QA/QI Specialist is responsible for 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 active engagement in the field through teaching, managing, and advancing the field by participation in professional meetings, publications, or presentations.

Responsibilities

• Perform and report on internal audits and assessments of laboratory processes to ensure compliance with JCAHO, AABB, FACT standards, FDA regulations, and outside sponsor audits.
• 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 the QA Manager in interactions with industry and government, including IND submissions, FDA registration, or licensure.
• Prepare for and participate in inspections and compliance audits.
• Lead and facilitate various quality processes (RCA, CAPA, Lean, and FMEA) to improve the department and report on laboratory’s performance.
• Manage 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 teams to propose improvement opportunities.
• Manage and report data for evaluation of clinical outcomes, including 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.
• Manage periodic review of assigned laboratory manuals, maintenance of archive files, and files of any other pertinent documentation for new or revised policies and procedures.
• Manage the continuing education program for laboratory personnel on relevant aspects of CMCF policies, procedures, and the Quality Program.
• Assist in the development of policies and procedures for product testing and release, and perform such testing. Provide training on procedures for CMCF laboratory personnel.
• Develop training modules and provide training in areas of subject matter expertise.
• Work within cGMP and cGTP guidelines and adhere to all regulatory standards within the Cell Manipulation Core Facility. Prepare and implement modules for GMP/GTP training.
• Train CMCF members and others on the safety program, clean room procedures, emergency preparedness, chemical, infectious agents, and radioactive hazards.
• Maintain continuing education records for laboratory employees.
• Verify that staff members adhere to department and section procedures and processes.
• Assist in the development, implementation, and monitoring of databases (engraftment, reactions, BOE, etc.) and information systems used in the department. Recommend audits for assessing performance of said databases.
• Perform pre- and post-processing review of batch records to assess compliance with clinical trial requirements.
• Serve as an independent auditor and verifier for assigned clinical trial procedures and processes.
• Perform QC, QA, and laboratory duties based on expertise.
• Participate in validation of new instruments and methods.
• Maintain records of procedures and resultant data, both manually and on computer.
• Participate as a CMCF representative/member at DFCI/BWH/BCH committees such as safety, Infection Control, etc.
• Evaluate new procedures, supplies, equipment, and clinical trials for unique attributes and requirements, and bring forth recommendations to CMCF leadership.
• Use resources (supplies, time, and people) in a responsible, cost-effective manner.
• Organize and prioritize multiple technical tasks with maximum efficiency and minimal waste.
• Perform other duties as assigned.

Requirements

• Working knowledge of basic and complex principles and practices of cell processing.
• Experience as an auditor and compliance specialist.
• Knowledgeable with all requirements of regulatory and accreditation agencies, including FACT, FDA, JCAHO, AABB, CLIA, DOT, DPH, and OSHA.
• Proficiency in working with computer databases and spreadsheets to extract, analyze, and maintain data.
• Experience with operation and troubleshooting of lab instrumentation and assay systems is desirable.
• Ability to use a wide variety of analytical techniques and instrumentation.
• Good judgment, problem-solving, and analytical skills.
• Strong interpersonal and communication skills to effectively interact with staff and physicians.
• Adherence to practices for aseptic technique.
• General lab skills and knowledge of lab safety and infection control.
• Knowledge and understanding of lab policies and procedures.
• Ability to work independently on off-shifts, handle stress, and produce accurate results under time constraints.
• Flexibility and adaptability to changing technology and work environments.
• Commitment to upgrading job skills and ongoing professional development.
• Ability to work closely with others in a diverse work group and accommodate schedule adjustments, off-shift, and weekend assignments as workload dictates.

Pay

$98,500.00 - $109,100.00