Lead Clinical Laboratory Scientist

FLSA Type: Non-exempt, Full-time (benefit eligible)

Department: Hospital Services

Work Days/Hours: Monday through Friday, 6:00 am - 1:30 pm (rotating on-call overnights, weekends, and holidays)

Reports to: Director of Hospital Services

Pay Range: $57.69 - $60.67/hourly

Pay Grade: 18

Work Modality: On-site

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

• 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

• Serves as CLIA Technical Supervisor

• Performs and maintains all QC logs, analyzes complex problems, and recommends additional service as needed

• 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

• Participates in planning and implementing change through participation in staff meetings, task forces or projects

• Demonstrates a commitment to working in a strong team environment and strict adherence to CCBC employee handbook and all company policies

• Demonstrates alignment with and adherence to the company's core values in all interactions, decisions, and work activities; serves as a role model for fostering a positive, respectful, and ethical workplace culture

• This position requires consistent, on-time attendance in accordance with company policy.…