Clinical Laboratory Scientist

Job Summary:

This position is responsible for performing moderate and high complexity laboratory testing on patient and donor samples and maintaining high complexity high throughput laboratory testing on blood donor specimens, interpreting and reporting results, performing quality control and quality assurance procedures, participating in regulatory inspections and complying with all applicable local, state, federal laboratory requirements, and following current Good Manufacturing Practices (cGMP).

Essential Responsibilities:

• Perform, interpret, and document complex antibody identification, compatibility testing, antigen typing, and donor serological testing.
• Prepare preliminary patient results reports for hospital customers.
• Manufacture special blood components such as frozen and deglycerolized red blood cells.
• Provide support and expertise to hospital customers regarding immunohematology testing.
• Reviews and finalizes donor testing results provided by outside testing laboratories.
• Reviews testing performed by other areas of the Laboratory (e.g., product QC and testing performed by Components).
• Demonstrates proficiency and follows laboratory standard operating procedures and policies by adherence to quality assurance guidelines for equipment and work area, documenting corrective action to any non-conforming event.
• Performs all assigned duties in compliance with internal SOPs and external regulations.
• Provides technical support/liaison to blood center operations.
• Performs and maintains all QC logs; analyzes complex problems; and recommends additional service, as needed.
• Prepares reagents and monitors required supply levels and alerts management when supplies should be ordered.
• Exercises clinical judgment in assessing priorities while identifying problems and offering solutions to test systems independently or through the appropriate department channels, i.e., contacts tech support to troubleshoot with a specialist, when necessary, to resolve the issue or set up service when appropriate.
• Assists with writing, reviewing, and revising internal standard operating procedures and documentation related to accreditation, adhering to all regulatory requirements for various authorities, including but not limited to CAP, CLIA, AABB, FDA, OSHA.
• Participates in planning and implementing change through participation in staff meetings, task forces, or projects.
• Assists with training and competency assessment of other team members.
• Demonstrate a commitment to working in a strong team environment.
• Demonstrate adherence to employee handbook and all company policies.

Note: The duties and responsibilities described above are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands.