What are the responsibilities and job description for the Biologics Laboratory Specialist position at SUNCOAST COMMUNITIES BLOOD BANK INC?
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.
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, 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 escalate 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.