Researcher/Scientist_Lab-Large Molecule
- 台北市南港區
- 3年以上
- 大學
The Researcher is responsible for the conduct of analysis related works according to GCP, GLP, CAP, Standard Operating Procedures (SOP), applicable Study Specific Procedures (SSP), and local regulatory requirements. Manage the operation of MT and aid physicians in the diagnosis, treatment, and prevention of diseases by testing patient specimens, correlating data, and reporting results in a timely manner to effect quality patient care. Responsibilities: Perform analysis work according to SOPs and guidance. Prepare, review, and approve various documents, including SOPs, protocols, reports, and analytical methods. Manage lab logistics, including purchasing, inventory control, and payment processing. Maintain instruments and ensure cleanliness and maintenance of the workspace. Take on the role of system owner for computerized systems, performing tasks such as validation tests, periodic reviews, and reporting. Attend training courses related to CAP/GCP/GLP/regulatory requirements. Study Based Responsibility (if needed) Analytical Study Director in Study Work as the Study Director, responsible for the overall conduct and final report of the study. Approve the study plan and any amendments by signature, and ensure Quality Assurance personnel receive timely copies. Make study plans, amendments, and SOPs available to study personnel. Ensure procedures in the study plan are followed and document deviations and take corrective action if necessary. Document and record all generated raw data. Validate computerized systems used in the study, sign and date the final report to indicate acceptance of responsibility for data validity, and ensure study materials are archived after completion. Study Personnel in Study Ensure personnel are knowledgeable in relevant Principles of Good Laboratory Practice. Provide study personnel with access to study plans and SOPs applicable to their involvement, with a responsibility to follow instructions and document any deviations. Emphasize the responsibility of all study personnel to promptly and accurately record raw data, comply with Good Laboratory Practice principles, and exercise health precautions to safeguard the integrity of the study.