Validation Specialist, Immunoassay

Labcorp•Indianapolis, IN

4d•Onsite

About The Position

Labcorp is seeking a Validation Specialist, Immunoassay to join their team in Indianapolis, IN. This role involves performing procedures for assay performance verification and clinical testing, with a strong analytical knowledge of sophisticated high-technology instrumentation. The specialist will act as a trainer for new employees on instrumentation and is responsible for achieving validation project deliverables within assigned timelines. This includes planning, documenting, performing bench work, analyzing and reporting data, and training the operational team on newly validated assays. The role also involves maintaining and troubleshooting instruments, acquiring specimens, improving processes, and collaborating with vendors for instrument service. Excellent written skills are required for generating validation plans, reports, and SOPs. The specialist will support inventory control for laboratory reagents and maintain accurate reagent quantities. Additionally, they are expected to maintain competencies on operational workflows to support client sample processing and other assigned duties. The role emphasizes adherence to safety policies, universal precaution guidelines, regulatory requirements, and Labcorp SOPs, maintaining an organized and safe laboratory environment. The specialist will demonstrate extensive knowledge of ELISA and automated immunoassay technologies and may serve as a departmental subject matter expert, potentially assisting operational staff with clinical sample testing.

Requirements

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.
Strong computer skills and experience with Microsoft Excel and Word.
Excellent verbal and written English skills.

Nice To Haves

ASCP or AMT certification

Responsibilities

Performs procedures for assay performance verification and clinical testing in assigned laboratory disciplines.
Provides training for new employees on sophisticated high-technology instrumentation.
Achieves all deliverables expected in a validation project within assigned timelines.
Performs tasks including planning, documenting, performing bench work, analysis of data, and reporting of data.
Trains operational team on newly validated assays.
Maintains, QC, acquires specimens, and proactively seeks opportunities to improve processes.
Demonstrates proven troubleshooting skills and identifies root causes in major areas of departmental responsibility.
Alerts management to instrument issues and interacts with the operations team to request instrument service from appropriate vendors.
Supports the generation of validation plans/reports and SOPs with supervision.
May interact with clients and vendors and supports scientists with the preparation of client-facing materials.
Completes relevant experiments associated with validation plans or other projects within determined timelines.
Supports inventory control for general laboratory reagents and maintains accurate reagent quantities based on project requirements.
Maintains competencies on assigned operational workflows to support operational staff for client sample processing or other duties.
Demonstrates thorough working knowledge 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.
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.
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.
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.
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.
Adheres to established Safety policies, Universal Precaution guidelines, regulatory requirements, and Labcorp SOPs at all times.
Maintains a clean, organized, and safe laboratory environment.
May assist operational staff with clinical sample testing and other laboratory activities as assigned by management.