Lead Clinical Laboratory Scientist

Job Summary

This position is responsible for performing moderate and high complexity laboratory testing on patient and donor samples, 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).

The Lead CLS is generally responsible for day-to-day testing operations, training or retraining, monitoring PM schedules, and inventory and reagent control. The Lead CLS also assists with outsourced donor testing, including reconciliation of results and working with QA on confirmatory testing.

Essential Responsibilities

· Assist in Quality Control and maintenance of current Good Manufacturing Practices (cGMP), document review, data log review, and instrumentation review.

· Perform, document and ensure regular timely maintenance as well as PM (Preventive Maintenance) of instrumentation.

· Train new testing staff on all SOPs, instrumentation function, electronic systems, workflow, including basic concepts and workflow in reference lab

· Review testing staff training forms, records and competencies.

· Assist with component documentation review.

· Contribute to review and update of testing SOPs.

· Responsible for inventory control including and ordering supplies and reagents as needed. Ensure reagents are rotated and not expiring on shelves. Evaluate standing orders.

· Responsible for discard and control of biohazardous waste including quarantine of products.

· Assist all laboratory staff in preparing for inspections.

· Demonstrate a commitment to working in a strong team environment.

· Performs, interprets, reviews, and documents complex antibody identification, compatibility testing, antigen typing, and donor serological testing

· Prepares preliminary patient results reports for hospital customers

· Assist with donor notification and lookbacks

· Cross-trains in platelet manufacturing, product QC testing, and component manufacturing to respond to operational needs

· Manufactures special blood components such as frozen and deglycerolized red blood cells

· Provides support and expertise to hospital customers regarding immunohematology testing

· Reviews and finalizes donor testing results provided by outside testing laboratories