Quality Assurance, Applications Specialist

The Opportunity

At Mass General Brigham Digital, we pride ourselves on our ability to create maximum strategic, clinical, and operational value from established and emergent technologies for our patients, care teams, researchers, and employees. Digital health will not only enhance the equity and efficiency of healthcare delivery, but it will also help make medicine more personalized and precise.

We recognize that increasing value and continually improving quality while maintaining an inclusive focus are essential to organizational excellence, and we invite you to join us on this journey. The work we do in Digital is a strategic imperative, and there is a strong and growing understanding of how together we will transform Mass General Brigham in innovative and impactful ways.

Research-infused care sets Mass General Brigham apart

As a national leader in innovation, our patient-centered mentality and systemwide collaborative approach are the keys to research breakthroughs that drive medical innovation, gain new knowledge, and improve patient outcomes. Our physician-scientists in the lab, in the clinic, and at the bedside work tirelessly to understand the effects of debilitating diseases and our patient needs to help guide our studies and improve patient care.

Mass General Brigham has over 200 years of leading innovative science, with 13 Nobel Laureates for research achievements and medical firsts. As a world-recognized leader in research, we are home to one of the largest hospital system-based research medical centers in the U.S., with anannual research budget of over $2 billion. Our researchers and clinicians are conducting thousands of studies in every major medical therapeutic and technology discipline. We are currently enrolling our patients in over2,700 ongoing clinical trials to accelerate bringing new treatments and therapies to our patients and the world.

Mass General Brigham is expanding support for the research community and seeking a Quality Assurance Specialist.

The Quality Assurance Specialist (QAS) is responsible for systems validation support for MGB Digital Research Operation Data Management and Integrity Tools, including: REDCap, LabArchives, StudyTRAX, Adobe, GitLab and additional research-focused applications. More info on our website: https://rc.partners.org/research-apps-and-services/collect-data

Digital Research Applications validation processes are designed to support all system life cycle activities on a per-phase basis; notably validation planning, system testing, system release/deployment, system maintenance. All validation deliverables are subject to audit by the Quality Assurance Specialist, to ensure conformance with Mass General Brigham internal policies and FDA regulatory requirements, including 21 CFR Part 11.

Principal Responsibilities:

• Ensure Digital Research Operations systems validation processes are in compliance with FDA regulatory standards and Mass General Brigham internal policies.
• Establish and track Systems Validation strategy and goals; lead continuous quality improvement efforts for the Digital Research Operations department.
• Proactively identify trends within the clinical research industry and provide Research Operations Leadership with regular feedback.
• Author and review validation documents and perform audits of testing and documentation generated in accordance with system validation plans and department Standard Operating Procedures (SOPs).
• Maintain a complete understanding of all department policies and procedures to execute all quality assurance tasks with minimal direct supervision.
• Provide assurance that Digital Research Operations GCP-regulated computerized systems perform according to predetermined specifications in an accurate, reliable and repeatable manner.
• Work collaboratively with team to ensure that all reviews are accurate, and that the reporting of results are done timely and accurately.
• Perform annual training for the department on Systems Validation documentation and deliverables, including Validation Master Plan (VMP), Requirements Specification (RS), Test Protocols IQ/OQ/PQ (TP), Requirements Traceability Matrix (RTM) and Validation Summary Report (VSR).
• Use the Mass General Brigham values to govern decisions, actions and behaviors. These values guide how we get our work done: Patients, Affordability, Accountability & Service Commitment, Decisiveness, Innovation & Thoughtful Risk; and how we treat each other: Diversity & Inclusion, Integrity & Respect, Learning, Continuous Improvement & Personal Growth, Teamwork & Collaboration.
• Other duties as assigned.

Qualifications:

• Education Bachelor's degree required
• 5+ years of healthcare information technology experience, software engineering, software quality assurance, or equivalent related experience
• Detailed working knowledge of FDA/FedRAMP/FISMA rules and regulations, specifically 21 CFR Part 11.
• Quality inspection, auditing, or testing experience requiredA combination of education and experience may be substituted for requirements
• Solid written and verbal communication skills essential
• Skills / Abilities / Competencies:
• Experience in the development, quality assurance or operations of validated software applications in a healthcare setting and/or FDA regulated environment.
• Organizational ability/attention to detail - Ability to work independently on assigned tasks, including planning, organizing, problem solving, and meeting established deadlines.
• Research Skills - Strong analytical skills and ability to thoroughly research topic areas needed for projects and integrate knowledge into training, quality assurance, and knowledge management processes.
• Strong interpersonal skills to interact positively and productively with a variety of personnel within the organization.
• Knowledge of Gherkin Syntax. Experience writing Gherkin test scripts: Familiarity with writing feature files in Gherkin format (Given-When-Then structure).
• Understanding of test scenarios: Ability to create clear, concise, and maintainable test cases.
• Experience with Behavior-Driven Development (BDD) and frameworks such as Cucumber, SpecFlow, or Behave.
• Cross-functional communication: Ability to communicate effectively with non-technical and technical stakeholders to gather requirements.
• Collaboration with stakeholders: Ability to work closely with product owners and developers to convert user stories into testable scenarios.
• Basic understanding of testing methodologies (unit, integration, functional, regression testing) and automation practices
• Knowledge of automation frameworks: Knowledge of integrating Gherkin with automation frameworks (e.g., Selenium, Cypress).
• Knowledge of Microsoft ADOKnowledge of Microsoft Office 365 and other popular office productivity solutions.

Supervisory Responsibilities

• No direct reports; will indirectly provide leadership and guidance to less seasoned and new staff.

Fiscal Responsibilities:

• Demonstrates fiscal responsibility by effectively using Mass General Brigham resources

Mass General Brigham is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.