Validation Specialist, Immunoassay

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

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.

As a "Labcorp expert," trains new employees in Labcorp processes, Good Clinical Practices, regulatory requirements, ELISA techniques, and…