IT QA Specialist

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM . Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL / RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

The primary responsibility of the IT QA Specialist is to assist in the management of areas of Quality Assurance (QA) and Information Technology (IT) related to Imaging Endpoints (IE) Core Lab Quality Management System (QMS). The IT QA Specialist positions will be solutions-oriented, facilitate timely quality decisions, and meet the needs of the business and all stakeholders with respect to quality assurance principles and practices.

IT QA SPECIALIST

RESPONSIBILITIES

• Provide quality system management within the regulations of investigational products and quality standards, specifically, 21 CFR Part 312, 21 CFR Part 211, 21 CFR Part 11, and ISO 13485.
• Provide direct QA support related to the IE QMS and Innovation and IT infrastructure.
• Develop, revise, implement, maintain the company’s Installation Qualifications (IQs), Operational Qualifications (OQs) and Performance Qualifications (PQs) to ensure system hardware and software validations follow all relevant regulations.
• Develop and implement validation / qualification protocols for clinical imaging data management tools and electronic systems.
• Responsible for the quality of documentation approved to support GxP activities for Imaging Endpoints and sponsor-related projects.
• Provide responses for Request for Information (RFI) questionnaire.
• Establish and implement QA procedures and controls to develop a compliant Core Lab QMS and Innovation and IT infrastructure.
• Review and approval of GxP documentation to ensure that guidelines are met.
• Interface with the Compliance and Regulatory Affairs department to implement quality system strategies and plans to facilitate continuous improvement of the regulated electronic systems.
• Aid in the generation of responses to inspectional findings and audits, as applicable.
• Interface with other areas of the organization to provide sound QA decision-making in areas that impact the Innovation and IT infrastructure and electronic systems.
• Interact with third parties in matters pertaining to information technology, regulatory, quality and compliance issues.
• Electronic document management experience in a regulated environment preferred.
• Facilitate good conduct of inspections and audits by communicating effectively, preparing documentation, training staff, and providing accurate information.
• Perform other duties as assigned by departmental management.

EDUCATION AND EXPERIENCE

SKILLS

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel : About 5 - 10% (domestic or international)