Validation Specialist, Immunoassay

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.

• 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.

• ASCP or AMT certification

Additional Job Standards:

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