Lead Clinical Laboratory Scientist

CLS Connect; Fresno (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

CLS Connect in Fresno leads laboratory testing operations, ensuring quality and regulatory compliance for patient and donor samples. The Lead CLS interprets results, manages SOPs, and coordinates QA and inspections while supporting donor testing and immunohematology services.

The role involves training staff, maintaining instrument PM schedules, inventory control, and cross-training in platelet manufacturing to support fluctuating operational needs.

Responsibilities

• Lead day-to-day testing operations and monitor PM schedules.
• Train new testing staff on SOPs and instrumentation.
• Maintain inventory and manage reagents to avoid expiry.
• Assist with outsourced donor testing and QA confirmatory testing.
• Prepare preliminary patient results reports for hospital customers.
• Support inspections and ensure compliance with cGMP, QA and regulatory requirements.
• Perform complex antibody identification, compatibility testing, and donor serology.
• Cross-train in platelet manufacturing and product QC to meet operational needs.
• Review testing staff records and competencies.
• Dispose of biohazardous waste properly and quarantine as required.
• Collaborate with QA on testing SOP updates.

Job description

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.

• 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