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;
• Buils 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;
• Led 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;
• Solves complex problems; escalates high-priority issues or risks, as appropriate;
• Maintains testing and training standards by developing technical and/or non-technical training materials and providing training;
• Participates in the evaluation of relevant personnel competency on an ongoing basis;
• Identifies training needs, ensures that personnel receive regular, in-service, and competency training, and completes 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;
• Conducts accreditation inspection processes, including communication with inspectors, lab supervisors, and managers;
• Monitoring the license renewal process;
• 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;
• 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;
• Leading and delivering ongoing technical and/or non-technical project management, including local, regional, and national initiatives, and status reports;
• Assists 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;
• Applying strategies to independently resolve moderately complex workflow concerns/problems.

Knowledge, Skills and Abilities

• (Core): Ambiguity/Uncertainty Management, Attention to Detail, Business Knowledge, Communication, Constructive Feedback, Critical Thinking, Cross-Group Collaboration, Decision Making, Dependability, Diversity, Equity, and Inclusion Support, Drives Results, Facilitation Skills, Health Care Industry, Influencing Others, Integrity, Leadership, Learning Agility, Organizational Savvy, Problem Solving, Short- and Long-term Learning & Recall, Strategic Thinking, Team Building, Teamwork, Topic-Specific Communication Knowledge, Skills and Abilities: (Functional): Compliance Management, Computer Literacy, Confidentiality, Employee Training, Health Care Compliance, Legal And Regulatory Requirements, Maintain Files and Records, Medical Sanitation and Infection Control, Member Service, Operations Management, Patient Sample Collection, Quality Assurance and Effectiveness, Quality Improvement, Safety Management

Minimum Qualifications

• Minimum two (2) years of experience working in a laboratory environment.
• Minimum one (1) year of experience in a leadership role with or without direct reports in a healthcare related field.
• Bachelor's degree in medical lab science or equivalent, or health care related field AND minimum four (4) years of experience in medical technology, clinical laboratory sciences, or health care related field OR Minimum seven (7) years of experience in medical technology, clinical laboratory sciences, or health care related field.
• One of the following licenses required at hire: Clinical Cytogeneticist Scientist License (California), Clinical Genetic Molecular Biologist Scientist License (California), Clinical Hematologist Scientist License (California), Clinical Histocompatibility Scientist License (California), Clinical Chemist Scientist License (California), Clinical Immunohematologist License (California), Clinical Microbiologist Scientist License (California), Clinical Reproductive Biologist Scientist License (California), Clinical Toxicologist Scientist License (California), Clinical Laboratory Scientist License (California).

Preferred Qualifications

• Master's degree in health sciences field.
• Doctorate degree in health sciences field.