Job Overview:
Essential Functions

• 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.

• Reagents/Materials/Supplies: 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.
• Training 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.

Education/Qualifications:
China Requirements

Required:

• Individual must qualify as testing personnel under MoH regulations.

Preferred:

• Bachelor's degree in Medical Technology or 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. Experience:

Required:
No prior experience is required.