Digital Pathology Specialist I – Histology Location: Aliso Viejo, CA Shift: Monday–Friday | 9:00 AM–5:30 PM Schedule may vary based on business needs. Job Description / Summary We are seeking a Digital Pathology Specialist I – Histology to support the implementation, validation, integration, and ongoing operation of AI-enabled digital pathology technologies. This position works with whole slide imaging (WSI), image management systems (IMS), digital pathology scanners, and AI/image analysis platforms. The Digital Pathology Specialist partners closely with laboratory operations, medical services, information technology, and external vendors to implement and optimize digital pathology solutions. The role also supports system validation, scanner deployments, technical troubleshooting, regulatory documentation, and the transition of new technologies into clinical production. Responsibilities Lead installation, implementation, and validation activities for digital pathology instruments and systems. Coordinate digital pathology scanning initiatives across laboratory operations, IT, medical services, and external vendors. Develop and execute validation study plans for whole slide imaging and AI-enabled technologies. Serve as a primary point of contact for scanner and image management system vendors during installations, deployments, and upgrades. Ensure site readiness prior to scanner installation, including network connectivity, storage connectivity, and integration testing. Lead validation activities for AI and image analysis algorithms prior to operational implementation. Prepare accurate and timely reports documenting validation activities, system performance, and technical findings. Support the transition of validated systems into clinical production and provide training to laboratory staff as needed. Troubleshoot scanner performance, instrumentation, workflow, integration, and testing issues. Lead the design, preparation, and implementation of IQ/OQ/PQ documentation with cross-functional teams. Participate in the development and implementation of AI-enabled laboratory equipment and tools. Assist with the preparation and maintenance of departmental forms, procedures, and SOPs. Ensure activities comply with applicable regulatory, medical, and operational requirements. Participate in departmental and site audits as needed. Collaborate with cross-functional teams to continuously improve digital pathology workflows and system performance. Travel approximately 20–30% as required. Qualifications / Requirements Minimum of 2 years of experience in digital pathology, laboratory operations, information technology, or a related environment. HT or HTL (ASCP) certification preferred. Knowledge of CAP Whole Slide Imaging (WSI) validation guidelines and digital pathology standards and best practices. Experience working with digital pathology scanners, whole slide imaging systems, image management systems (IMS), and/or AI/image analysis platforms. Solid understanding of histology and general laboratory techniques. Knowledge of laboratory regulatory and compliance requirements. Experience with system or instrument validation, including IQ/OQ/PQ, strongly preferred. Strong technical troubleshooting and problem-solving skills. Ability to accurately document complex scientific and technical information. Strong organizational skills with excellent attention to detail. Ability to collaborate effectively with laboratory, medical, IT, and vendor teams. Ability and willingness to travel approximately 20–30%.
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