LAB Coordinator

Laboratory Validation CoordinatorCellular 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.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 shortagesCollaborate with Cellular Therapy, Quality Assurance, and Laboratory personnel to develop, validate, implement, and optimize procedures supporting cellular therapy product manufacturing and testingTrain 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 assaysExecute validation and qualification protocols, including sample preparation, testing, data collection, analysis, and documentation in accordance with approved plans and proceduresCompile, organize, analyze, and present validation data; prepare summary reports, acceptance criteria evaluations, and final validation packages for Quality Assurance review and approvalMaintain validation records, raw data, batch records, facility records, and process documentation in accordance with Good Documentation Practice (GDP) standards and applicable regulatory requirementsDraft, revise, and implement standard operating procedures (SOPs), work instructions, and related training materials associated with new or modified methods, processes, and proceduresConduct analytical testing, method qualifications, and method validations to support GMP manufacturing and the implementation of new testing and assessment proceduresCoordinate validation and pre-production activities with internal departments and external clients to support cellular therapy manufacturing operationsSupport the Quality Management System (QMS) through participation in validation-related deviations, corrective and preventive actions (CAPAs), change controls, risk assessments, and continuous improvement initiativesMonitor and document quality control activities and ensure instrument maintenance, calibration, and procedural requirements are completed in accordance with established policies and proceduresInvestigate, 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 appropriateExercise professional judgment in evaluating specimen integrity, test validity, and result accuracy, taking appropriate corrective action to ensure reliable and compliant laboratory testingFollow established procedures for specimen handling, processing, testing, result reporting, and record retention during both routine and validation activitiesParticipate in the preparation and presentation of technical data through reports, publications, and presentations at internal meetings and professional conferencesPlan, execute, and document method validations and qualifications related to the Special Testing LaboratoryServe as the primary liaison between the laboratory and Quality Assurance for validation activitiesCompile validation data and prepare associated reports, records, and documentationSupport the implementation of validated methods into routine laboratory operationsTrain on and perform routine cellular therapy testing procedures to maintain bench competencyMust have the ability to work variable shifts (day, night, weekends and/or holidays) as neededMinimum Qualifications:Bachelor's degree in Clinical Laboratory, Chemical, or Biological Science requiredOne (1) year of pertinent laboratory experience requiredKnowledge of FDA regulations (21 CFR Parts 210, 211, 606, 610, 1271), cGMP/cGxP standards, and AABB/FACT-JACIE accreditation standardsKnowledge of Good Documentation Practice (GDP) standardsKnowledge of laboratory testing methodologies, validation principles, and quality systemsUnderstanding of regulatory requirements governing laboratory operationsUnderstanding of regulatory requirements governing cellular therapy operationsAbility to troubleshoot testing and validation issues and implement corrective actionsAbility to exercise professional judgment regarding specimen integrity, result accuracy, and test validityAbility to communicate technical information through written reports, presentations, publications, and stakeholder discussionsAbility to coordinate validation projects and collaborate with Quality Assurance and laboratory personnelTwo (2) years of relevant laboratory or quality experience with experience in cellular therapy testing or manufacturing, with development or optimization of testing or processes, preferredPrevious experience in cell or tissue culture preferredPrevious experience in flow cytometry and cellular assays preferredExperience working in a research and development environment is preferredHigher level education, such as master's degree in relevant field, is preferredThis position also requires applicants to have experience in, or an understanding of, the following:Aseptic processing in ISO 5 biosafety cabinetsUniversal precautions for handling human derived materials in BSL-2 containment areasCell culture and expansionCell washing processes and automated equipmentCell separation techniques and automated equipmentCell quality testingWho Are We:LifeSouth is a non-profit community blood bank serving more than 150 hospitals in Alabama, Florida, Georgia and Tennessee. We are committed to meeting the blood supply needs of hospitals and their patients by providing the highest quality blood components and services. With more than 45 donor centers, 55 bloodmobiles and 2,000 blood drives a month, our LifeSouth team is dedicated to making sure the blood is there when you or your family is in need.Our Mission:To provide a safe blood supply that meets or exceeds the needs in each community we serve, and to provide a variety of services in support of ongoing and emerging blood and transfusion related activities.This is a full-time position. Starting salary range is $70,000 - $84,000 per year. Criminal background check and drug screen required upon conditional offer of hire. Equal Opportunity/Affirmative Action Employer/Drug-Free/Tobacco Free Workplace.LifeSouth is a Drug-Free and Tobacco-Free Workplace. LifeSouth is a VEVRAA Federal Contractor as well as an affirmative action employer and provides equal opportunity to all persons, regardless of race, religion, age, gender, disability, status as a protected veteran, national origin, color, or any other classification in accordance with federal, state, and local statutes, regulations and ordinances. Veterans are encouraged to self-identify as LifeSouth desires to provide protected veterans priority referrals for open positions. LifeSouth complies with all laws and regulations associated with the Family Medical Leave Act (FMLA) and the Americans with Disability Act (ADA). LifeSouth is an E-Verify employer.If you require any assistance to complete the application process or during the interview due to a disability, please contact the LifeSouth region where you are applying or call View phone number on click.appcast.io to request an accommodation. Applications may be completed at a LifeSouth facility or mailed to corporate headquarters in lieu of the on-line application process.