QA/QI Specialist

Dana-Farber Cancer Institute; Boston (MA); On-site; USD 76,000 - 86,000; Full time

Job summary

Dana-Farber Cancer Institute in Boston is seeking a QA/QI Specialist II to lead quality assurance and improvement activities. You will monitor, analyze outcomes, and develop initiatives to drive sustained improvements while preparing for external audits and inspections.

The role requires compiling data, performing complex audits, and collaborating with physicians and leadership to meet regulatory and policy standards. Strong Excel, data analysis, and project management skills are essential.

Qualifications

• Bachelor's degree in a relevant field.
• 4 years of experience in related field (cell therapies, clinical laboratory, research, clinical setting, biologic/pharma industry or similar).
• 2 years of quality assurance or advanced cell therapy experience in another area of specialization.

Responsibilities

• Carries out and/or leads monitoring efforts and populates dashboard and key indicator data sets.
• Develops, supports, and/or leads quality improvement initiatives; links QA to outcomes via data.
• Reviews documentation and assesses effectiveness of documentation review approaches; analyzes causes and develops solutions.
• Develops and carries out complex audits to ensure compliance with standards and regulations.
• Performs outcome analysis and presents findings to physicians, investigators, leadership, or stakeholders.
• Prepares teams for external audits; conducts readiness checks and drafts responses.
• Maintains employee records of training and credentialing per regulatory standards.
• Routes and revises controlled documents; maintains records and archives per retention rules.
• Assists with CAPA plans and follow-up audits to verify effects.
• Assists QA Manager with training and supervision of QA/QI staff.
• Provides training and support to staff and clinicians.

Skills

Excel

Data analysis

Project management

Communication

Attention to detail

Independent work

Multitasking

Analytical thinking

Education

Bachelor's degree in a relevant field

Job description

The QA/QI Specialist II supports and leads quality assurance and quality improvement activities by conducting monitoring efforts, maintaining dashboards and key indicator data sets, and analyzing outcomes to identify trends, risks, and opportunities for improvement. The role develops, implements, and evaluates quality improvement initiatives; performs complex audits and documentation reviews to assess compliance with applicable standards, regulations, policies, and procedures; and recommends corrective and preventive actions to address identified deficiencies and measure sustained improvement. This position also prepares teams for external audits and inspections through readiness assessments, evidence compilation, response drafting, and follow-up activities.

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

• Carries out and/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.
• Reviews documentation and assesses effectiveness of documentation review approaches; analyzes causes and develops solutions for documentation failures.
• Develops and carries out complex or qualification audits requiring content and operational knowledge of activity being audited to ensure compliance against standards, regulations, procedures and policies.
• Performs outcome analysis, including reviewing, interpreting, and reporting relevant information as assigned and presenting to physicians, investigators, leadership, or other stakeholders.
• Prepares teams for external audits and inspections. Performs readiness checks, compiles evidence, and drafts responses.
• Maintains employee records of training and credentialing as required by unit activity assigned and associated regulatory standards.
• Routes and revises controlled documents; prepares fillable forms, maintain records, and archives per retention requirements.
• Assists with correction and preventative action (CAPA) plans based on audit findings, deviations and events. Plans follow up audits to assess if the desired effect / change was achieved.
• Assists QA Manager in providing training, support, and supervision to QI-I staff.
• Provides training and support to relevant staff and clinicians in areas of expertise.

Knowledge, Skills and Abilities

• Strong knowledgeof applicable standards and regulations to ensure department/institution ongoing compliance with accreditation standards and inspection regulations.
• Subject matter expertise (e.g., donor services, data management, informatics, clinical operations, or other assigned program areas) to help the department/program achieve its stated objectives and goals for overall improvement.
• Strong Excel skills.
• Knowledge of medical, hematologic, oncologic, and scientific terminology preferred.
• Ability to compile data and analyze using statistical tools.
• Ability to understand the enterprise environment and competing priorities in conjunction with developing/meeting project goals.
• Strong project management skills.
• Strong written and verbal communication skills.
• Strong analytical and problem‑solving skills.
• Attention to detail and interpersonal skills to effectively communicate with staff and physicians.
• Ability to work independently, manage multiple priorities, and adapt to change.

Minimum Job Qualifications

• Bachelor's degree in a relevant field required.
• 4 years of experience in related field (cell therapies, clinical laboratory, research, clinical setting, biologic/pharma industry or similar) required.
• 2 years of quality assurance or advanced cell therapy experience (e.g., trainer, lead, senior or equivalent) in another area of specialization required.

License/Certification/Registration Required: None

Supervisory Responsibilities: No

Patient Contact: No

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusiveenvironment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are committed to having faculty and staff who offer multifaceted experiences. Cancer knows no boundaries and when it comes to hiring the most dedicated and compassionateprofessionals, neither do we. If working in this kind of organization inspires you,

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 characteristics protected by law.

Pay Transparency Statement

The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.

For union positions, the pay range is determined by the Collective Bargaining Agreement (CBA).

$75,900.00 - $85,500.00