Dana-Farber Cancer Institute
Located in Boston, Dana Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals
Applications are being accepted for the position of QA/QI Specialist II for the Cell Manipulation Core Facility, a clinical and clinical research laboratory that processes and manufactures cellular products for the treatment of patients. The QA/QI Specialist, reporting to the QA Manager for the facility, is responsible for monitoring operations and developing and managing quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current and adhered to by staff. Expected to understand and apply principles of quality management practices to the monitoring and improvement of the operation. Key areas of focus may include patient and staff safety, clinical laboratory, cell processing, tissue banking, and other specified departmental procedures and policies as assigned. Will support validation of laboratory procedures, collect and analyze data, and perform routine document review and special audits. Plays key role in supporting preparation and provide on site support during site surveys and audits by regulatory agencies. Plays a key role as a member of multidisciplinary teams. Additionally, provides training and support to relevant staff (CMCF, KFBDC, Clinicians, etc) in areas of expertise.
BS/BA degree in science, medical technology (MT,SBB,etc) or related field required. Minimum of 5 years of experience in related field (clinical laboratory, blood bank, clinical setting, biologic/pharma industry), at least 3 years of quality and regulatory experience preferred, or advance degree in related field and 3 years in quality of regulatory experience.
Monday through Friday. 40 hours.