Essential Functions
Perform assigned clinical laboratory testing accurately and in a timely manner.
Resolve pendings. Retrieve and check specimens against pending list. Document specimen discrepancies. Notify laboratory management when specimen discrepancies are not resolved.
Prepare workstation and instrumentation for the assigned testing.
Properly handle specimens and independently resolve technical specimen issues in preparation for analysis and specimen storage. Contact internal customers for clarification as needed.
Operate instruments to perform testing in accordance with established written procedures.
Performs routine testing and calculations as required.
Resolve routine and non-routine assay problems.
Ensure the validity of tests results through the performance of established quality assurance and quality control procedures.
Perform experiments, as scheduled, for evaluation of new Calibrator and/or QC lots.
Summarize results of investigations and compile data for review by management.
Document quality control results. Interpret quality control results according to Westgard rules or other established departmental procedures and accurately document biases, warnings and violations of control values.
Document corrective action for unusual occurrences (e.g. QC violations, instrument related problems).
Analyze proficiency testing survey samples as patient specimens.
Reagents/Materials/Supplies:
Receive, open and place in service all reagents/materials according to SOPs.
Prepare and properly label reagent, quality control, calibrator material.
Document implementation of new reagents/materials according to SOPs.
Perform parallel testing, linearity’s, stability, other quality control practices needed to ensure validity of material prior to being placed into service.
Perform inventory control of supplies and reagents as approved by management.
Result Entry (Auto-verification and manual entry).
When data is manually entered (e.g. QC, patient data) ensure peer review is performed and documented prior to release of results.
Prepare proper documentation of test results and enter into the information system.
Generate an appropriate audit trail for all activities.
Document and communicate any result reporting problems or inconsistencies to laboratory management.
Complete testing within the expected turnaround time to meet customers’ expectations.
Ensures maintenance of instruments and equipment is performed according to manufacturer and SOP requirements and documented according to SOP.
Calibrate instruments, equipment and/or assays as required and document.
Perform basic instrument and equipment troubleshooting.
Perform pipette calibrations and document according to SOP.
Notify laboratory management when an instrument or equipment does not meet specifications.
Comply with regulatory guidelines and Covance Standard Operating Procedures (SOPs) at all times.
Individual must qualify as testing personnel under the following CLIA 1988 and New York State Department of Health requirements:
Bachelor’s degree in Medical Technology or Clinical Laboratory Science or other life science with completion of at least a 12-month training program in Medical Technology.
OR
Bachelor’s degree in a chemical, physical or biological science from an accredited college or university and one year training and/or experience in the specialty in which testing is to be performed. Such training must be equivalent to that received in a school of Medical Technology.
OR
90 semester hours from an accredited institution that include the following:
1) 16 semester hours of biology courses, which are pertinent to the medical sciences
2) 16 semester hours of chemistry (at least 6 semester hours of Inorganic Chemistry)
3) 3 semester hours of math
• Completed an accredited clinical laboratory training program, or one year documented laboratory training or experience in the specialty that testing is to be performed.
OR
Associate’s degree in medical laboratory technology
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