Histology Validation Specialist I

• Assay Development and Validation:

• Performs specific validations-related laboratory tasks within timelines assigned by Staff and/or Lead scientist.
• Maintains laboratory and project related sample, reagent and disposable inventory
• Assist Staff and Lead scientist with developing project reagent order plans (Participate to the identification and the sourcing of reagents/commercial samples/equipment needed for assay validation. Requesting quotes to the Procurement team and interacting with vendors when needed)
• Instruments/Equipment:

• Demonstrates working knowledge (operation and maintenance processes, calibration) of department specific instruments as well as common laboratory equipment and notify laboratory management when an instrument or equipment does not comply with regulatory guidelines and Labcorp SOP.
• Able to provide troubleshooting to resolve complex instrument and equipment problems. Works with the vendor where needed to resolve issues and summarizes results of investigations.
• Performs instrument setup and QC according to SOPs.
• Performs laboratory maintenance tasks in collaboration with operations.
• Training:

• Assists with the development and complete timely review of new or revised training materials circulated for peer review.
• Seeks to promote expertise in the department and across sites to ensure consistent approach to validation of assays.
• Assists with training operation employees on newly validated assay and follows-up to ensure training is understood.
• The individual successfully completes, as scheduled, competency assessment, and ensures competency testing documentation is provided to management for review/retention.
• Competently performs department duties as set forth in the department training checklist(s).
• SOPs:

• Complete timely review of new or revised SOPs, checklists, and worksheets circulated for peer review.
• May assist with timely processing of SOPs for department.
• Validation Plans/Validation Reports:

• Supports with the writing of validation plans, reports, and SOPs with assistance from Staff and Lead scientists.
• Appropriately document work performed in compliance with Labcorp SOPs (generate appropriate audit trail for all activities)
• Participates in meetings as requested by listening, discussing, and critically evaluating own data and that presented by others.
• Interacts with scientists to prepare client-facing materials (timelines, datasets, and presentations).
• Additional responsibilities:

• Adheres to established Safety policies and Universal Precaution guidelines at all times. Maintains a clean, organized and safe work environment. Minimizes biohazard waste.
• Complies with regulatory guidelines and Labcorp Standard Operating Procedures (SOPs) at all times.
• May assist operational staff in the processing of clinical samples and other responsibilities to support testing as assigned by the direct manager.

• Bachelor’s Degree in Biology.

• 5 year or more working experience in clinical laboratory Histology testing.
• CET-4 or higher certification.

• Verbal and written English skills.
• Computer skills and experience with Microsoft Excel and Word

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