Clinical Laboratory Specialist

4 weeks ago

Shanghai, Shanghai, China SHG Labcorp Pharmaceutical Research and Development (Shanghai) Co., Ltd. Full time

As a Clinical Laboratory Specialist at SHG Labcorp Pharmaceutical Research and Development (Shanghai) Co., Ltd., you will play a vital role in ensuring the accuracy and reliability of laboratory test results. Your responsibilities will include analyzing specimens, reviewing and investigating unacceptable results, and preparing corrective action responses. You will also assist with the development of training material, training checklists, and competency assessment programs.

Key Responsibilities:

Quality Control Monitoring Programs

• Review and investigate unacceptable results to internal and external quality control monitoring programs.

• Prepare corrective action responses by assigned due date for management review.

SOPs

• Complete timely review of new or revised SOPs circulated for peer review.

• Assist with timely processing of SOPs for the department.

Proficiency Testing Survey Samples

• Provide support to the proficiency testing program by coordinating receipt of survey material, coordinating with interdepartmental personnel for sample analysis, and ensuring timely and correct completion of electronic or paper report forms.

• Investigate root cause for unacceptable performance on proficiency surveys and prepare corrective action response by assigned due date.

Training

• Assist with training new employees and follow up to ensure training is understood.

• Assist with the development of training material, training checklists, and competency assessment programs.

Instrument/Equipment/Assay Validation

• Assist with assay validations by performing experiments according to departmental SOP. Compile validation data for management review.

• Assist with validation of new equipment and instruments including software validation requirements (e.g., User Acceptance Testing).

• Assist staff by providing technical guidance where needed.

Equal Opportunity Employer:

SHG Labcorp Pharmaceutical Research and Development (Shanghai) Co., Ltd. is an Equal Opportunity Employer and does not discriminate based on race, religion, color, national origin, gender, family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

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