Assay Validation Specialist

Labcorp•Torrance, CA

1d•$25 - $39•Onsite

About The Position

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

Requirements

High School Diploma
One year experience in laboratory assay validation or related work within a histology lab
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

Nice To Haves

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

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