Biologics Laboratory Specialist

Job Details

Job Location:

Lakewood Ranch - Bradenton, FL 34211

Position Type:
Full Time Education Level: Bachelor's degree or equivalent experien

Job Category:
Science

• 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.

• 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.

• 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 Sun Coast 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 Sun Coast 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.

• 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.

• 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…