職位描述
Duties and Responsibilities:
1. Mainly focus on clinical laboratory testing for non-Tox studies accurately and in a timely manner.
? Work with sponsor on assay development. Resolve routine and non-routine assay problems.
? Retrieve and check specimens against pending list. Document and resolve any specimen discrepancies. Notify laboratory management when specimen discrepancies are not resolved.
? Prepare workstation and instrumentation for the assigned testing.
? Receive, open and place in service all reagents according to SOPs.
? Prepare and properly label reagents and document according to SOPs.
? Operate instruments to perform testing in accordance with established written procedures.
? Evaluates and solves problems related to the collection and processing of specimens.
2. Ensure the validity of test results through the performance of established quality control procedures. Interpret quality control results according to established departmental procedures.
? Prepare quality control material accurately.
? Report the quality control results to the management, troubleshoot, and take corrective action on questionable or out-of-limit results. Documents all corrective actions and submits them for review by the management.
3. Result Entry
? Prepare proper documentation of test results and enter into the information system.
? Document and report any result reporting problems or inconsistencies to laboratory management.
? Complete testing within the expected turn around time to meet customers’ expectations.
4. Perform maintenance on instruments and equipment daily, weekly, monthly, and document.
? Ensure that maintenance is performed and documented according to SOP.
? Perform basic instrument and equipment troubleshooting with assistance.
? Resolve the problems when an instrument or equipment does not meet specifications.
5.Regulatory compliance
? Comply with regulatory guidelines, Universal Precautions and Covance Standard Operating Procedures (SOPs) at all times.
6. Demonstrate proficiency in applicable computer systems and software. Operate and utilize all communications systems available in the laboratory; telephones, copiers, facsimile machines and pagers.
7. Participates in proficiency testing and maintains a record of on-going competency along with personal training file.
8. Maintain a clean, organized and safe work environment. . Handles hazardous materials, reagents and chemicals in a safe manner according to SOP.
9. Exercises and maintains levels of competence, integrity and interpersonal skills necessary to attain regulatory and quality goals.
10. Coordinate IHC works with APO team to ensure study timeline.
11. Other duties as assigned
Education/Qualifications:
? Minimum bachelor degree in Life Sciences, medical laboratory technology or equivalent. Master degree is preferred.
Experience:
? A minimum of 3-5 year experience working in clinpath or diagnostic lab.
? A minimum 2 years assay development experience.
Location: 上海浦東新區康新公路3377號
