Laboratory Validation Coordinator

Laboratory Validation Coordinator

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.

Responsibilities Include (but are not limited to):

• 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 escalate 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 procedures for specimen handling, processing, testing, result reporting, and record retention during both routine and validation activities
• Participate in the preparation and presentation of technical data through reports, publications, and presentations at internal meetings and professional conferences
• Plan, execute, and document method validations and qualifications related to the Special Testing Laboratory
• Serve as the primary liaison between the laboratory and Quality Assurance for validation activities
• Compile validation data and prepare associated reports, records, and documentation
• Support the implementation of validated methods into routine laboratory operations
• Train on and perform routine cellular therapy testing procedures to maintain bench competency
• Must have the ability to work variable shifts (day, night, weekends and/or holidays) as needed

Minimum Qualifications:

• Bachelor's degree in Clinical Laboratory, Chemical, or Biological Science required
• One (1) year of pertinent laboratory experience required
• Knowledge of FDA regulations (21 CFR Parts 210, 211, 606, 610, 1271), cGMP/cGxP standards, and AABB/FACT-JACIE accreditation standards
• Knowledge of Good Documentation Practice (GDP) standards
• Knowledge of laboratory testing methodologies, validation principles, and quality systems
• Understanding of regulatory requirements governing laboratory operations
• Understanding of regulatory requirements governing cellular therapy operations
• Ability to troubleshoot…