Laboratory Validation Coordinator

Laboratory Validation Coordinator LifeSouth Community Blood Centers - 2.6 Gainesville, FL Job Details Full-time $70,000 - $84,000 a year 12 hours ago Benefits Wellness program Health savings account Health insurance Dental insurance Paid time off Vision insurance 403(b) Life insurance Qualifications Biological safety protocols Immunological assays ISO standards Immunological laboratory techniques Good documentation practices (GDP) Biochemical laboratory techniques Bachelor's degree Automated systems Regulatory/legal compliance standards in production Biomedical regulatory compliance Sterile products production GMP for research safety and compliance Test validation method Project stakeholder communication FDA regulations Assays Full Job 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. 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. •Must have the ability to work variable shifts (Weekends and/or Holidays) as needed•Our 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 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 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 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 This position also requires applicants to have experience in, or an understanding of, the following: 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 Who 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. The position description may not include all the duties and responsibilities of the job. Duties and responsibilities that are not listed, but which the employee may be expected to perform, will fall within the scope of the skills, knowledge and training for the position. 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 1-888-795-2707 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.