Assay Validation Specialist

Labcorp is seeking an Assay Validation Specialist to join our team in Torrance, CA.

Work Schedule: Monday-Friday 9am-5:30pm

This position focuses on assay validation, verification, and laboratory method development.

The role supports validation projects from planning through testing to reporting while ensuring compliance with GxP, CAP, and CLIA standards. The Assay Validation Specialist will be responsible for achieving all the deliverables expected in a validation project within the timeline assigned by the Staff and/or Lead scientists.

Job Responsibilities

• Execute immunohistochemistry (IHC) validation and verification experiments and other methods as applicable
• Demonstrate working knowledge of department specific instruments (such as IHC autostainers) and equipment
• Support development and writing of validation plans, reports, SOPs, pathology report forms, and study setup forms
• Perform data analysis and documentation
• Prepare client-facing materials
• Maintain and organize validation documentation
• Organize and scan slides as required according to protocols
• Regularly provide status update and report to the Staff and/or Lead scientists
• Act as a liaison between scientific side and lab staff to train and communicate new methods to the clinical testing staff
• Perform validation-related testing, screenings, and proficiency testing
• Execute preparing samples incl. decalcification, processing, embedding, microtomy, and re-embedding of human commercial tissue specimens for validation
• Perform routine, special stains, and advances staining (e.g. IHC) assays and other techniques according to SOPs, protocols, and in line with global and regional regulatory requirements
• Utilize knowledge and experience with histology samples to maintain proper storage conditions and facilitate labelling of commercial/validation blocks and slides (stained and unstained)
• Adheres to lab safety policies and universal precaution guidelines at all times
• Maintains clean workspaces
• Operate, maintain, and troubleshoot lab instruments
• Perform QC checks and manage vendor interactions
• Inform management and lab operations about instrument issues and handle service requests
• Work with scientists and operations globally
• Ensure consistent approach to validation of assays
• Proactively support training and seek process improvements

• High School Diploma

• One year experience in laboratory assay validation or related work within a histology lab

• Associate's Degree in Chemical or Biological science or related field
• Three years experience in assay validation or method development
• One year experience with embedding, microtomy, and sample preparation
• One year experience in regulated lab environment

• Strong attention to detail
• Ability to manage timelines
• Good written and verbal communication skills
• Troubleshooting capability
• Dynamic attitude and ability to work under pressure
• Proficiency in Excel and Word
• Good record keeping
• Theoretical and practical knowledge of histology standard techniques
• Strong documentation and written skills
• Able to pass a standardized color blindness test