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Job Description:

Essential Functions:
  • Perform assigned clinical laboratory testing accurately and in a timely manner.
  • Resolve pendings.
  • Retrieve and check specimens against the 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, linearitys, 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.
  • Training Individual is responsible for maintaining candidates complete up-to-date training file and is accountable for correcting and deficiencies found in Candidate's/Candidate's training file.
  • Individual is responsible for ensuring Candidate is trained and training is documented prior to performing a task.
  • The individual successfully completes, as scheduled, competency assessment and ensures competency testing documentation is provided to management for review/retention.
  • Competently performs department duties as set forth in the department training checklist(s).
  • May assist in training new employees and follows-up to ensure training is understood.
  • Attends, as scheduled, department, mandatory and other meetings and training, as required according to training matrices.
  • Work to achieve partnership with both internal customers and external clients by:
  • Pull data in a timely manner for review by QA and external clients.
  • Contribute to the provision of accurate verbal or written response to internal QA and client audit findings.
  • Coordinate, where needed, with other resources to resolve issue.
  • Researches and prepares a response following investigation for quality purposes.
  • Coordinate, where needed, with other resources to resolve issue.
  • Research and responds in a timely manner to internal customer inquiries regarding status of test results, retrieval of samples for testing/storage and other needs.
  • Understand department metrics and goals.
  • Demonstrate proficiency in applicable computer systems and software.
  • Adheres to established Safety policies and Universal precaution guidelines at all times.
  • Maintains a clean, organized and safe work environment.
  • Minimizes biohazard waste.
  • Cleans workstation and materials daily.
  • Takes action for the department when additional responsibilities and opportunities are presented.
  • Provide laboratory management with a report of activities upon request.
  • Other duties as assigned.
Scope:
  • Principal Contacts and Scope of Communications.
  • Internal Lab management, Lab Assistants, Technologists, Warehouse, LPS, SM, IT - Ongoing.
  • External Technical service instrument manufacturer- Ongoing.
Experience:
  • No prior experience is required.
  • Education/Qualifications/Certifications and Licenses.
  • Individual must qualify as testing personnel under the following CLIA 1988.
  • Bachelors 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.
  • Bachelors 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.
  • 90 semester hours from an accredited institution that include the following:
  • 16 semester hours of biology courses, which are pertinent to the medical sciences.
  • 16 semester hours of chemistry (at least 6 semester hours of Inorganic Chemistry)
  • 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.
  • Associates degree in medical laboratory technology.
Competencies:
  • Focus on clients.
  • Innovate and change.
  • Develop self and teams.
  • Work well with others.
  • Get it done.
Working Conditions:
  • Work is generally performed in a laboratory environment.
  • Exposure to blood borne pathogens.
  • Potential exposure to hazardous chemicals.
Special Factors:
  • Weekend work and bank holidays is required.
  • Second or third shift may be required.
  • Overtime may be required.

Last updated on Jul 20, 2023

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