Quality Control Lab CLS II

Job Title: Quality Control Lab CLS II

Department: Quality Control Laboratory

Reports to: Quality Control Laboratory Supervisor

Risk of Exposure to Bloodborne Pathogens: Yes

Has Direct Reports: No

Will be required to drive company vehicle: No

Job Summary

Under minimal supervision of management, Clinical Laboratory Scientist (CLS) perform manufacturing processes in a highly regulated environment-from receipt of unprocessed apheresis platelets, through maintaining accurate records of finished components in preparation to distribute to available inventory. The Quality Control (QC) lab CLSs test products across the three stages of production (before, in-process, and final) and review the data to ensure the high quality and maximum efficacy of blood components.

Responsibilities

• Perform essential laboratory responsibilities according to established procedures.
• Support the San Diego Blood Bank (SDBB) safety, GMP and Quality Plan. Adheres to GMP guidelines.
• Safely operate laboratory equipment in accordance with established Standard Operating Procedures (SOPs).
• Obtain samples for product QC testing and further manufacturing.
• Perform donor and product quality control evaluations.
• Perform sterility testing on apheresis platelets and operate bacterial detection instrument.
• Perform pathogen reduction process using illuminator instrument.
• Operate Hematology analyzer to manufacture platelets using large volume delayed sampling and pathogen reduction methods.
• Perform pH analysis using pH Meters
• Perform residual WBC testing using Fluorescence Microscopy method.
• Perform routine equipment QC and maintenance.
• Evaluate, gather data, trend, and assess results.
• Assist in training new personnel and other staff members.
• Assist in laboratory paperwork documenting information accurately and completely in a timely manner.
• Complete all tests required for each product.
• Initiate and participate in the investigations and assess any potential impact on product quality. Conduct retesting of product as needed to support quality investigations.
• Participate in research projects.
• Participate in department meetings and educational programs.
• Review and approve quality control on products, reagents, and various test kits.
• Receive / Review, Upload and Commit IDM test results.
• Provide support for the donor notification/look-back process.
• Perform Iso titration on platelet components.
• Communicate with production personnel and Quality Assurance department.
• Assist with validations, special projects, and new process developments.
• Monitor supply inventory levels and assist with material ordering.
• Understand and adhere to the policies and standards as developed as part of the San Diego Blood Bank Compliance Program.
• Perform other related duties as assigned or requested.

Working Environment

• Normal laboratory environment with biohazard precautions.
• May be exposed to blood or bodily fluids that may be capable of transmitting diseases.
• May be exposed to chemicals that may be hazardous.
• May be called on to work or attend meetings at other than routinely scheduled hours.

Physical Requirements

• Must be able to stand or sit long hours.
• Must be able to work on a computer 4 - 8 hours a day.
• Must be able to communicate clearly.
• May be required to lift to 40 pounds.

Equipment Used

• General office equipment (computer, printer, fax, copy machine).
• Various software systems (Blood Establishment Computer System, Quality Management System).
• Laboratory equipment, including, but not limited to:

• Centrifuges.
• Heat sealers.
• Scales.
• Refrigerators/incubators.
• Sterile Connection Devices.
• Bacterial detection 3D analyzer.
• Hematology cell counter.
• Illuminators.
• ADAM rWBC analyzer.
• pH Meter.

Qualifications

Education:

• MLS(ASCP)/MT(AAB, AMT)
• CA Clinical Laboratory Scientist (CLS)- Generalist license is required.

Experience:

• Laboratory experience: Minimum of 2 years blood banking or related experience.
• Understanding of technical aspects of the laboratory, blood banking concepts, hematology, microbiology, serology, and flow cytometry.

Skills:

• Organized and able to efficiently prioritize and handle multiple tasks at one time to provide a productive workflow.
• Professional communication both written and oral, which is clear and precise.
• Provide direct and constant supervision over unlicensed laboratory personnel.
• Must be detail oriented, well organized and display good time management skills.
• Ability to perform under pressure and work under stressful situations.
• Interpersonal skills to establish and maintain professional relationships.

The above statements are intended to describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Pay Range: $52.50 - $62.68 per hour