Laboratory Validation Coordinator

Description

Cellular therapies are advancing faster than most labs can validate them. We're looking for someone who wants to be at that front edge — designing, executing, and documenting the validations that turn emerging methods into routine, compliant testing.

Life South Community Blood Centers is looking for an individual to join our team as a Laboratory Validation Coordinator in Gainesville, FL
. This position supports the development, implementation, and continuous improvement of testing processes within the Special Testing Laboratory by coordinating and managing method validation and qualification activities. This role serves as a key resource in the evaluation and introduction of new laboratory methods and technologies, ensuring validated processes are successfully integrated into laboratory operations while supporting compliance with applicable quality and regulatory standards.

• Paid Time Off (PTO) plan
• Medical, dental, and vision insurances available to full-time employees the first of the month after 60 days
• Supplemental insurances including life, cancer, accident, and disability
• Access to mental wellness resources and counseling through telehealth
• Free basic life insurance for full-time employees
• Health Savings Account (HSA) with employer match each pay period
• Employer funded retirement plan for vested employees & 403b offered
• Employee wellness program
• Access to wages prior to pay day
• Shift differential for applicable evening and overnight hours

• Perform routine laboratory testing to maintain technical proficiency, support laboratory operations, and serve as bench coverage during absences, high-volume periods, or staffing shortages
• Collaborate with Cellular Therapy, Quality Assurance, and Laboratory personnel to develop, validate, implement, and optimize procedures supporting cellular therapy product manufacturing and testing
• Train on, maintain competency in, and perform cellular therapy testing procedures conducted within the Special Testing Laboratory, including but not limited to flow cytometry, cell counting, viability assessment, sterility testing, and identity/potency assays
• Execute validation and qualification protocols, including sample preparation, testing, data collection, analysis, and documentation in accordance with approved plans and procedures
• Compile, organize, analyze, and present validation data; prepare summary reports, acceptance criteria evaluations, and final validation packages for Quality Assurance review and approval
• Maintain validation records, raw data, batch records, facility records, and process documentation in accordance with Good Documentation Practice (GDP) standards and applicable regulatory requirements
• Draft, revise, and implement standard operating procedures (SOPs), work instructions, and related training materials associated with new or modified methods, processes, and procedures
• Conduct analytical testing, method qualifications, and method validations to support GMP manufacturing and the implementation of new testing and assessment procedures
• Coordinate validation and pre-production activities with internal departments and external clients to support cellular therapy manufacturing operations
• Support the Quality Management System (QMS) through participation in validation-related deviations, corrective and preventive actions (CAPAs), change controls, risk assessments, and continuous improvement initiatives
• Monitor and document quality control activities and ensure instrument maintenance, calibration, and procedural requirements are completed in accordance with established policies and procedures
• Investigate, troubleshoot, and resolve issues identified during validation or routine testing; document corrective actions and elevate concerns that may affect test performance, product quality, or result reporting as appropriate
• Exercise professional judgment in evaluating specimen integrity, test validity, and result accuracy, taking appropriate corrective action to ensure reliable and compliant laboratory testing
• Follow established…