Incumbent performs established procedures for clinical testing as required in all assigned laboratory disciplines. Incumbent is responsible for analyzing specimens whose results are then reported to the sponsor.
♦ Perform assigned clinical laboratory testing accurately and in a timely manner.
o Resolve pendings. Retrieve and check specimens against pending list. Document specimen discrepancies. Notify laboratory management when specimen discrepancies are not resolved.
o Prepare workstation and instrumentation for the assigned testing.
o Properly handle specimens and independently resolve technical specimen issues in preparation for analysis and specimen storage. Contact internal customers for clarification as needed.
o Operate instruments to perform testing in accordance with established written procedures.
o Performs routine testing and calculations as required.
o Resolve routine and non-routine assay problems.
♦ Ensure the validity of tests results through the performance of established quality assurance and quality control procedures.
o Perform experiments, as scheduled, for evaluation of new Calibrator and/or QC lots.
Summarize results of investigations and compile data for review by management.
o 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.
o Document corrective action for unusual occurrences (e.g. QC violations, instrument related problems).
o Analyze proficiency testing survey samples as patient specimens.
o Receive, open and place in service all reagents/materials according to SOPs.
o Prepare and properly label reagent, quality control, calibrator material.
o Document implementation of new reagents/materials according to SOPs.
o Perform parallel testing, linearity’s, stability, other quality control practices needed to ensure validity of material prior to being placed into service.
o Perform inventory control of supplies and reagents as approved by management.
♦ Result Entry (Auto-verification and manual entry).
o When data is manually entered (e.g. QC, patient data) ensure peer review is performed and documented prior to release of results.
o Prepare proper documentation of test results and enter into the information system.
o Generate an appropriate audit trail for all activities.
o Document and communicate any result reporting problems or inconsistencies to laboratory management.
o 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.
o Calibrate instruments, equipment and/or assays as required and document.
o Perform basic instrument and equipment troubleshooting.
o Perform pipette calibrations and document according to SOP.
o 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.
o Individual is responsible for maintaining his/her complete up-to-date training file and is accountable for correcting and deficiencies found in his/her training file.
o Individual is responsible for ensuring he/she is trained and training is documented prior to performing a task.
o The individual successfully completes, as scheduled, competency assessment and ensures competency testing documentation is provided to management for review/retention.
o Competently performs department duties as set forth in the department training checklist(s).
o May assist in training new employees and follows-up to ensure training is understood.
o 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:
o Pull data in a timely manner for review by QA and external clients.
o 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.
o Researches and prepares a response following investigation for quality purposes.
Coordinate, where needed, with other resources to resolve issue.
o 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.
o 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.