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 knowledge of area assigned, carries out monitoring, documentation review, data gathering and some limited data analysis, basic audits, and support for quality improvement initiatives. Supports multidisciplinary teams in developing and carrying out quality improvement initiatives as assigned.

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.

PRIMARY DUTIES AND RESPONSIBILITIES:

• 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

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• 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.

MINIMUM JOB QUALIFICATIONS:

The position requires a BS/BA degree in science, medical technology, or a related field. Candidates must have at least 5 years of experience in a relevant field, such as clinical laboratories, blood banks, clinical settings, or the biologic/pharma industry.

SUPERVISORY RESPONSIBILITIES:

Provides training and support to relevant staff (CMCF, KFBDC, Clinicians, etc) in areas of expertise. No direct reports.

PATIENT CONTACT:

Limited contact with patients, donors and families, but extensive review of patient?s / donor?s medical records (adults and pediatrics).