Laboratory Validation Coordinator

LifeSouth Community Blood Centers•Gainesville, FL

7h•$70,000 - $84,000•Onsite

About The Position

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. LifeSouth 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.

Requirements

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 testing and validation issues and implement corrective actions
Ability to exercise professional judgment regarding specimen integrity, result accuracy, and test validity
Ability to communicate technical information through written reports, presentations, publications, and stakeholder discussions
Ability to coordinate validation projects and collaborate with Quality Assurance and laboratory personnel
Aseptic processing in ISO 5 biosafety cabinets
Universal precautions for handling human derived materials in BSL-2 containment areas
Cell culture and expansion
Cell washing processes and automated equipment
Cell separation techniques and automated equipment
Cell quality testing

Nice To Haves

Two (2) years of relevant laboratory or quality experience with experience in cellular therapy testing or manufacturing, with development or optimization of testing or processes, preferred
Previous experience in cell or tissue culture preferred
Previous experience in flow cytometry and cellular assays preferred
Experience working in a research and development environment is preferred
Higher level education, such as master’s degree in relevant field, is preferred

Responsibilities

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

Benefits

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