Lead Clinical Laboratory Scientist

CENTRAL CALIFORNIA BLOOD CENTER•Fresno, CA

10d•Onsite

About The Position

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.

Requirements

Current California CLS or CIS license is required and must be maintained
Knowledge of safety precautions required for working with bloodborne pathogens is required
+3 years of laboratory testing experience is required
Constant computer use (keyboard, mouse)
Frequent lifting/carrying between 0-10 lbs.
Frequent sitting
Frequent standing
Frequent walking
Frequent handling (holding, light grasping)
Occasional bending at the neck
Occasional bending at the waist
Occasional twisting at the beck
Occasional twisting at the waist
Occasional pushing and pulling
Infrequent lifting/carrying between 11-25lbs.
Infrequent reaching below shoulder
Infrequent fine fingering (pinching, picking)
Constant operating of hazardous machinery
Frequent exposure to excessive noise
Occasional work in close proximity to others
Environmentally controlled laboratory environment
Infrequent exposure to extreme cold temperatures, and could be required to enter walk-in freezer at 32°F or lower
Infrequent walking on slippery and uneven surfaces
Must wear Personal Protective Equipment (PPE) such as gloves, mask or goggles
Possible exposure to bloodborne pathogens

Nice To Haves

Certified SBB/BB or equivalent.
IRL or complex blood banking experience is preferred

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. Excessive tardiness or absenteeism may impact performance and employment status
Employees in this role are entitled and expected to take compliant meal and rest periods in accordance with California law.