Validation Specialist I, Medical Laboratory

Job Summary

In addition to the responsibilities listed below, this position is also responsible for performing initial testing and setup procedures (e.g., validation, verification, calibration, sensitivity studies) for new or replaced instruments; supporting assay development; and contributing to the implementation and performance of validation plans.

Essential Responsibilities

• Promotes learning in others by proactively providing and/or developing information, resources, advice, and expertise with coworkers and members; builds relationships with cross-functional/external stakeholders and customers. Listens to, seeks, and addresses performance feedback; proactively provides actionable feedback to others and to managers. Pursues self-development; creates and executes plans to capitalize on strengths and develop weaknesses; leads by influencing others through technical explanations and examples and provides options and recommendations. Adopts new responsibilities; adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; champions change and helps others adapt to new tasks and processes. Facilitates team collaboration to support a business outcome.
• Completes work assignments autonomously and supports business-specific projects by applying expertise in subject area and business knowledge to generate creative solutions; encourages team members to adapt to and follow all procedures and policies. Collaborates cross-functionally and/or externally to achieve effective business decisions; provides recommendations and solves complex problems; escalates high-priority issues or risks, as appropriate; monitors progress and results. Supports the development of work plans to meet business priorities and deadlines; identifies resources to accomplish priorities and deadlines. Identifies, speaks up, and capitalizes on improvement opportunities across teams; uses influence to guide others and engages stakeholders to achieve appropriate solutions.
• Maintains testing and training standards by developing technical and/or non-technical training materials and providing training; participating in the evaluation of relevant personnel competency on an ongoing basis; and identifying training needs, ensuring that personnel receive regular, in-service, and competency training, and completing own training.
• Maintains compliance and accreditation by developing policies and work instructions in alignment with applicable regulations, license requirements, accreditation standards, and inspection checklists pertaining to laboratories and facilities where testing is performed; leading adherence to all requirements related to the recruitment, processing, testing, storage, and distribution of materials and samples; conducting accreditation inspection processes, including communication with inspectors, lab supervisors, and managers; monitoring the license renewal process; and independently updating technical and/or non-technical documentation.
• Serves as a link between medical laboratory services and other services by maintaining awareness of regulatory/accreditation changes and issues, inspection citations, current events, and trends relevant to services, quality, and training; contributing to cross-functional teams to proactively evaluate and improve technical and/or non-technical quality management systems; networking and collaborating across internal teams locally to coordinate and align lab operations, quality, and utilization;and applying local and national standards, regulations, technology, and initiatives.
• Maintains medical laboratory operations and improves processes by advocating for efficient operations, quality, service, patient safety, member/customer satisfaction, and cost effectiveness through evaluation and standardization of technical and/or non-technical services and processes; designing work plan processes to improve systems across the continuum of care; researching new testing methodologies, processes, and technology that have the potential to improve service, quality, and/or efficiency; resolving moderately complex laboratory and patient/member problems; collaborating with staff to ensure teamwork and a progressive work environment; coordinating day-to-day laboratory operations; implementing inventory and maintenance systems, inventorying supplies, and reporting usage and costs; and leading and delivering ongoing technical and/or non-technical project management, including local, regional, and national initiatives, and status reports.
• Coordinates service quality by assisting in the development of and modeling applicable policies and procedures for audit and process improvement projects; independently conducting internal audit processes to verify quality of technical and/or non-technical processes; addressing deviations from expected quality control results; ensuring that tests are performed properly and results are verified before being shared; collecting, preparing, running, and reviewing specimens and ensuring they are collected and processed according to established time and quality standards; reporting and tracking proficiency testing performance; and applying strategies to independently resolve moderately complex workflow concerns/problems.