Biologics Laboratory Specialist

Biologics Laboratory Specialist

Lakewood Ranch - Bradenton, FL 34211

Job Description

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 escalate 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 Expectations

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

Minimum 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