Quality Assurance IT Specialist

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). 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. 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 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. Establish and implement QA procedures and controls to develop a compliant Core Lab QMS and Innovation and IT infrastructure. Interface with the Compliance and Regulatory Affairs department to implement quality system strategies and plans to facilitate continuous improvement of the regulated electronic systems. 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. EDUCATION AND EXPERIENCE Bachelor’s degree in information technology, Computer Science, or related fields. Five (3) years of experience in regulated industries with at least two (2) years in pharmaceuticals or medical devices. Imaging Core Lab experience desired. Familiarity with medical imaging applications and DICOM network is preferred. Knowledge of Windows server and VMWare, Citrix, Active Directory, LAN, and desktop operating systems (Windows 10, macOS) preferred. Electronic document management experience in a regulated environment preferred. GAMP 5), and experience in reviewing and approving hardware and software validation reports. Experience in preparation and/or review of documents submitted to FDA for review. QMS experience is preferred. Quality risk management experience preferred. Proficiency in Microsoft Office and internet applications required. Excellent hands-on computer skills with thorough knowledge of Microsoft Office, including Excel and PowerPoint (statistics, graphing, presentations, etc.). Proficiency in Microsoft Office and internet applications required. Knowledge of Windows server as well as with VMWare, Citrix, Active Directory, and desktop operating systems (Windows 10 and Mac) is a plus. Knowledge of Risk-based validation practices and Software Life Cycle (SDLC) management. Knowledge of Microsoft Office 365 preferred. Service-oriented approach, flexible, and proactive. Must maintain strict confidentiality of sensitive data, records, files, conversations, etc. Ability to excel in a team environment. Strong organization and planning skills. Ability to manage projects and deliverables with high accuracy and completeness. Self-driven, ability to get the job done with little supervision, positive can-do attitude. Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints we enjoy advancing clinical trials, helping patients, and celebrating success we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else Travel: About 5 - 10% (domestic or international)