Validation Specialist, Immunoassay

CLS Labcorp Central Laboratory Services Limited Partnership; Indianapolis (IN); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life

STD/LTD

401(k)

PTO/FTO

Tuition Reimbursement

Employee Stock Purchase Plan

Job summary

CLS Labcorp Central Laboratory Services Limited Partnership in Indianapolis, IN is seeking a Validation Specialist, Immunoassay to perform validation activities and support immunoassay operations. The role includes developing and executing validation plans, documenting results, and assisting with client-facing data and SOPs.

The ideal candidate has a biology degree, extensive immunoassay experience, and strong communication skills, with proficiency in Excel and Word.

Qualifications

• Bachelors degree in Biology (or related field).
• Strong analytical skills and attention to detail.
• Excellent written and verbal English communication.

Responsibilities

• Performs validation tasks for immunoassay methods and devices.
• Prepares validation plans, protocols and reports.
• Trains staff on validated assays and SOPs.
• Maintains inventory and supports instrument maintenance and troubleshooting.

Education

Bachelors degree in Biology or related field

Tools

ELISA platforms

Immunoassay instruments

Excel

Word

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

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

• Medical
• Dental
• Vision
• Life
• STD/LTD
• 401(k)
• Paid Time Off (PTO) or Flexible Time Off (FTO)
• Tuition Reimbursement
• 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.

Equal Opportunity Statement

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. 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.

Closure

We believe in the power of science to change lives. Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Here, you can join our nearly 70,000 employees, serving clients in more than 100 countries, as we work together to transform approaches to patient care.