Clinical Laboratory Scientist Lead

CLS Connect; Fresno (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

CLS Connect in Fresno, CA seeks a Lead CLS responsible for high-complexity lab testing on patient and donor samples, interpreting results and ensuring QA and cGMP compliance. The Lead CLS oversees day-to-day testing operations, training, PM scheduling, and inventory control.

You will assist with outsourced donor testing, manage instrumentation maintenance, review SOPs, and support inspections while fostering a collaborative team environment.

Qualifications

• Perform complex antibody identification and donor serological testing.
• Maintain cGMP compliance through documentation and data review.
• Train staff on SOPs, instrumentation and workflows.
• Review staff training records and competencies.
• Manage inventory and reagent control to prevent expirations.

Responsibilities

• Assist in quality control and cGMP documentation.
• Perform preventive maintenance of instrumentation and document results.
• Train new testing staff on SOPs and electronic systems.
• Ensure inventory control and reagent rotation.
• Support donor testing and reconcile results with QA.
• Prepare preliminary patient results reports for hospital customers.
• Review donor testing results from outside labs.
• Assist with inspections and maintain strong team collaboration.

Skills

Quality Control

cGMP knowledge

Training & mentoring

Instrumentation maintenance

Regulatory compliance

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