Located in Boston and the surrounding communities, 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.
The Cell Manipulation Core Facility (CMCF) is gearing up to begin a large clinical trial and is hiring additional staff specifically for this project. This position is to support this project which has an expected duration of approximately two and a half years dependent on enrollment.
This position will be dedicated to the ongoing quality assurance oversight focused on this particular project. Candidate must be able to work closely with Sponsor and others on the team. Close attention to detail is a must. Candidate must be able to work flexible hours, as needed. Experience with flow cytometry and pcr is desired, but not required.
The QA/QI Specialist 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 in the assigned unit or department. Expected to understand and apply principles of quality management practices to the monitoring and improvement of the operations for the unit(s) assigned. Key areas of focus may include patient and staff safety, clinical laboratory, cell processing, donor blood product collections, tissue banking, clinical operations, and other specified departmental procedures and policies as assigned. Plays key role in supporting preparation and on site support during site surveys and audits by regulatory agencies. Works with multidisciplinary teams and may be assigned to work under the direction of physician or nursing staff for assigned initiatives.
Applying significant knowledge of area assigned, carries out or leads monitoring efforts and populates dashboard and key indicator data sets
Develops, supports, and/or leads quality improvement initiatives; develops approaches to linking quality improvement to outcomes reported through dashboard or key indicator data or surveys and observation studies
Works with institutional leadership to develop improvement efforts
Reviews documentation and assesses effectiveness of documentation review approaches; analyses causes and develops solutions for documentation failures
Gathers data and/or develops research and data analysis projects
Develops and carries out complex audits requiring content and operational knowledge of activity being audited
Maintains employee records of training and credentialing as required by unit activity assigned and associated regulatory standards
Can perform audits to ensure compliance against standards, regulations, procedures, policies, IND/IDE and clinical trials.
Perform trending and analyzing of data using appropriate quality and statistical tools. Assist in reporting data within and external to the department, institution, across institutions, and to governmental agencies
Assist / develop training documentation, review/audit competency assessments and training documentation to ensure that employee record corresponds with tasks employee is performing
CAPA - Assist with correction and preventative action plans based on audit findings, deviations and events. Plan follow up audits to assess if the desired effect / change was achieved
BS/BA degree in science, medical technology (MT,SBB,etc) or related field required. Minimum of 6 years of experience in related field (clinical laboratory, blood bank, clinical setting, biologic/pharma industry), which includes 3 years of related quality and regulatory experience, or advance degree in related field and 3 years in quality of regulatory experience.
Maintain basic knowledge of applicable standards and regulations to ensure department / institution ongoing compliance with accreditation standards (FACT, JC) and inspection regulations (FDA, DPH,CMS, DOT)
Outcome analysis - Review / interpret / report relevant information as assigned or to present to physician or other investigator
Subject matter expertise - provide assistance in a given area of expertise (microbiology, immunohematology, cell processing, informatics, clinical operations etc) to help the department / program achieve its stated objectives and goals for the overall improvement of the program
Strong Excel skills required.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.
Since its founding in 1947, Dana-Farber Cancer Institute in Boston, Massachusetts has been committed to providing adults and children with cancer with the best treatment available today while developing tomorrow's cures through cutting-edge research. Read about our history, our breakthroughs, and the resources that help us support the health of our neighborhoods and communities.?