Validation Specialist, Immunoassay

Job description

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives. Labcorp is seeking a Validation Specialist, Immunoassay to join our team in Indianapolis, IN! Work Schedule: Monday-Friday 8am-5pm Job Responsibilities: Performs procedures for assay performance verification, clinical testing as required in all assigned laboratory disciplines with strong analytical knowledge of sophisticated high technology instrumentation and act as a trainer for new employees on the same. The Validation Specialist will be responsible for achieving all of the deliverables expected in a validation project within timeline assigned by the Staff and/or Lead scientists. This will include performing tasks like planning, documenting, performing bench work, analysis of data, reporting of data and train operational team on newly validated assays. The Specialist shall maintain, QC, acquire specimens, proactively seeks out opportunities to improve processes and demonstrate proven troubleshooting skills, identifying root cause, in major areas of departmental responsibility . The Specialist is responsible for alerting management to instrument issues and will be required to interact with the operations team to request instrument service from appropriate vendor. Excellent written skills are required for supporting the generation of validation plans/reports and SOPs with supervision from staff and/or Lead scientists. The Specialist may at times be included on communication with clients and vendors and will support the scientists with the preparation of client-facing materials. All relevant experiments associated with validation plans or other project are expected to be completed within timelines determined by management. The Specialist will support inventory control for general laboratory reagents and will be responsible for maintaining accurate reagent quantities based on project requirements, all in collaborations with scientists and operations. The Validation Specialist is expected to maintain competencies on assigned operational workflows such that they are able to provide support to operational staff for client sample processing or any other duties as assigned by their manager. Instruments/Equipment Demonstrates thorough working knowledge (operation, maintenance processes, calibration, and troubleshooting) of automated immunoassay platforms, ELISA plate readers, washers, liquid handling systems, and common laboratory equipment. Provides guidance to staff in resolving complex instrument and equipment issues and works with vendors as needed. Performs instrument setup, system suitability, QC, and maintenance according to SOPs. Notifies laboratory management when instruments or equipment do not comply with regulatory requirements or Labcorp SOPs. Training As a "Labcorp expert," trains new employees in Labcorp processes, Good Clinical Practices, regulatory requirements, ELISA techniques, and automated immunoassay procedures. Assists with the development and review of training materials. Supports training of operational staff on newly validated assays and ensures competency requirements are completed and documented. SOPs Completes timely review of new or revised SOPs, worksheets, and checklists circulated for peer review. Assists with SOP processing and authors new or revised SOPs to ensure compliance and alignment with current laboratory practices. Coordinates with other departments and sites to support consistent assay practices and documentation. Validation Plans/Validation Reports Supports preparation of validation plans, protocols, reports, and technical documentation. Documents work performed in compliance with Labcorp SOPs and maintains appropriate audit trails. Participates in scientific discussions and assists with preparation of client-facing datasets, timelines, and presentations. Assay Development and Validation Performs ELISA and automated immunoassay development, optimization, transfer, and validation activities within assigned timelines. Executes validation experiments to evaluate assay performance characteristics including accuracy, precision, sensitivity, specificity, selectivity, dilutional linearity, robustness, and stability. Supports qualification of critical reagents, controls, reference standards, and assay components. Maintains laboratory and project-related sample, reagent, and consumable inventories. Assists Staff and Lead Scientists with sourcing materials and equipment required for assay development and validation. Additional Responsibilities Behaves as an example by adhering to established Safety policies, Universal Precaution guidelines, regulatory requirements, and Labcorp SOPs at all times. Maintains a clean, organized, and safe laboratory environment. Demonstrates extensive knowledge of ELISA and automated immunoassay technologies and may serve as a departmental subject matter expert. May assist operational staff with clinical sample testing and other laboratory activities as assigned by management. Minimum Qualifications: Bachelor’s degree in Biology (or related field) Five years or more of external clinical laboratory testing or 3 years or more of Labcorp laboratory experience performing clinical testing or/and assay validation related tasks. Preferred Qualifications: ASCP or AMT certification Additional Job Standards: Strong computer skills and experience with Microsoft Excel and Word. Excellent verbal and written English skills. Pay Range: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. For more detailed information, please click here . Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement .