Biologics Laboratory Specialist

Job DetailsJob Location: Lakewood Ranch - Bradenton, FL 34211Position Type: Full TimeEducation Level: Bachelor's degree or equivalent experienJob Category: Science ESSENTIAL JOB FUNCTIONS Laboratory Support Support assigned Laboratory operations within the employee's documented training, competency, qualifications, and authorized scope. Perform daily temperature monitoring and assigned instrument quality control activities. Monitor equipment, storage conditions, and other assigned technical processes and promptly report abnormalities, failures, or out-of-range conditions. Respond to Isensix alarms during assigned shifts in accordance with established procedures. Assist with technical documentation, record review, data entry, and other assigned Laboratory activities. Support Laboratory workflow and operational needs as assigned and within demonstrated competency. Assist with troubleshooting and resolution of technical or operational issues within assigned scope and elevate concerns when appropriate. Product Manufacturing and Blood Product Support Support Product Manufacturing activities associated with the processing, labeling, quarantine, storage, release, and distribution readiness of blood products. Perform product quarantine and release activities within documented training, competency, authorization, and established procedures. Label applicable blood products, including LRBCs, FFP, Liquid Plasma, Platelets, and other products as assigned, as required testing results become available. Verify product information and documentation for accuracy and completeness before completing assigned processing or labeling activities. Monitor blood product status and assist with ensuring products move appropriately through manufacturing, testing, quarantine, labeling, and release processes. Assist with maintaining appropriate product storage, organization, rotation, and handling in accordance with established procedures. Support Product Manufacturing workflow and assist with operational needs based on workload and collection activity. Quality Control and Documentation Perform assigned daily quality control activities and maintain complete and accurate documentation. Support monthly quality control data entry and review within Kintavo or other designated SunCoast Blood Centers systems. Review assigned records for completeness and accuracy and promptly communicate discrepancies or concerns. Assist with tracking, documenting, and resolving quality control issues within assigned scope. Maintain documentation in accordance with SunCoast Blood Centers policies, standard operating procedures, regulatory requirements, and applicable quality standards. Participate in quality improvement and process improvement activities involving Laboratory and Product Manufacturing operations. Procedures, Training, Competency, and Staff Support Assist departmental leadership with the review, revision, and implementation of standard operating procedures. Provide technical guidance and support to staff on processes for which the Technical Services Specialist has demonstrated competency and has been authorized to provide assistance. Assist with training and cross-training staff on assigned Laboratory and Product Manufacturing procedures within demonstrated competency and under the direction of departmental leadership. Support staff orientation and competency activities, including demonstrating established procedures, reinforcing proper technique, and assisting with training documentation as assigned. Help identify areas where additional staff education, procedural clarification, or reinforcement may be beneficial and communicate those needs to departmental leadership. Support consistent application of established procedures while recognizing that formal performance management, supervisory direction, and final competency authorization remain the responsibility of designated leadership. Participate in additional technical education, cross-training, observational experiences, and professional development opportunities to expand knowledge of Laboratory and Product Manufacturing operations. Maintain required training and competencies for all assigned functions. Cross-Functional Operational Support Work across Laboratory and Product Manufacturing functions based on workload, staffing, collection activity, and operational needs. Assist departmental leadership with identifying workflow issues, technical barriers, and opportunities to improve efficiency and coordination between Laboratory and Product Manufacturing. Support timely movement of blood products through testing, manufacturing, labeling, quarantine, release, and availability for distribution. Communicate effectively between Laboratory, Product Manufacturing, Quality, and other departments regarding product status, technical concerns, and operational needs. Provide coverage and technical support within documented competency and authorization as operational needs require. Regulatory, Quality, and Safety Perform assigned responsibilities in accordance with SunCoast Blood Centers policies, standard operating procedures, quality requirements, safety practices, and applicable regulatory standards. Follow established procedures for blood product handling, labeling, storage, quarantine, release, documentation, and traceability. Immediately report errors, deviations, equipment concerns, product discrepancies, safety concerns, or other issues that may affect product quality or regulatory compliance. Participate in inspections, audits, corrective actions, process improvements, and other quality activities as requested. Maintain required documentation, training, and competency records. Performance will be evaluated based on accuracy and quality of work; maintenance of required competencies; adherence to established procedures and regulatory requirements; effectiveness in supporting both Laboratory and Product Manufacturing operations; timely completion of assigned responsibilities; quality of documentation; teamwork and communication; reliability; technical development; appropriate support of staff training and competency activities; and contribution to efficient blood product processing and availability. Additional Responsibilities Participate in departmental meetings, training, competency assessments, professional development, and SunCoast Blood Centers initiatives as required. Maintain current knowledge of assigned procedures and technical responsibilities. Provide support during periods of increased collection activity, staffing needs, or other operational demands. Perform other duties as assigned to support SunCoast Blood Centers operations. PHYSICAL AND ENVIRONMENTAL REQUIREMENTS Physical Requirements Ability to stand, walk, and work in laboratory and product manufacturing environments for extended periods. Ability to sit and use a computer for documentation, data entry, and other assigned activities. Manual dexterity and visual acuity sufficient to perform detailed technical activities, product labeling, documentation, and equipment operation. Ability to bend, reach, push, pull, and perform repetitive movements associated with laboratory and blood product processing activities. Ability to lift and carry up to 30 pounds as required for assigned duties. Environmental Requirements Work is primarily performed in Laboratory and Product Manufacturing environments. Regular interaction with blood, blood components, biological materials, laboratory equipment, refrigerators, freezers, and other technical equipment. Potential exposure to bloodborne pathogens, biohazardous materials, chemicals, and other occupational hazards associated with blood banking and laboratory operations. Required use of appropriate personal protective equipment and adherence to applicable safety and infection control standards. May require work in refrigerated or temperature-controlled environments for limited periods. ADDITIONAL REQUIREMENTS Must complete and maintain all required SunCoast Blood Centers training and competency requirements for assigned functions. Must perform only those technical activities for which appropriate training, competency, qualifications, and authorization have been established. Functions requiring specific professional licensure, certification, or credentials may only be performed when the employee meets applicable requirements and has been authorized by SunCoast Blood Centers. Regular, reliable, and timely attendance is essential. Ability to work flexible hours, including evenings, weekends, holidays, or extended hours as operational needs require. Ability to respond to changing operational priorities and provide cross-functional support as needed. Qualifications Education Bachelor's degree in biological science, medical laboratory science, clinical laboratory science, or a related scientific field required. Advanced education in a related scientific or healthcare field preferred. Experience Previous experience in a blood bank, laboratory, healthcare, biologics, manufacturing, or regulated technical environment preferred. Experience with blood component processing, laboratory operations, quality control, or blood product handling preferred. An equivalent combination of relevant education, training, and experience may be considered. Knowledge, Skills, and Abilities Working knowledge of laboratory, blood banking, biologics, or blood product manufacturing principles. Ability to follow established standard operating procedures, quality requirements, safety practices, and regulatory standards. Strong attention to detail and accuracy when performing product labeling, documentation, quality control, and other technical activities. Ability to learn and maintain competency in multiple technical functions across Laboratory and Product Manufacturing operations. Ability to recognize problems, appropriately elevate concerns, and assist with resolution within assigned scope. Strong organizational and time-management skills with the ability to manage multiple priorities in a regulated environment. Ability to accurately enter, review, and maintain technical and quality-related data. Ability to assist with training and reinforcement of established procedures within areas of demonstrated competency. Strong verbal and written communication skills. Ability to work effectively and collaboratively with Laboratory, Product Manufacturing, Quality, and other SunCoast Blood Centers departments. Ability to maintain confidentiality and appropriately handle sensitive donor, patient, product, and organizational information. CORE COMPETENCIES AND EXPECTATIONS Demonstrates accuracy, reliability, and attention to detail in all assigned technical functions. Maintains required training and competency for assigned responsibilities. Follows established procedures and appropriately escalates deviations, discrepancies, or concerns. Demonstrates flexibility and willingness to support both Laboratory and Product Manufacturing operations. Works collaboratively with team members and departmental leadership to support operational needs. Demonstrates initiative in developing technical knowledge and expanding cross-functional competencies. Communicates technical information clearly and supports staff learning within assigned areas of competency. Maintains professionalism, accountability, and a commitment to quality, safety, and SunCoast Blood Centers mission. #J-18808-Ljbffr Suncoast Communities Blood Bank