Company: Suzhou Chengyao Biotechnology Suzhou Chengyao Biotechnology Co., Ltd.
Recruitment type: full-time
Position title: Bioanalytical topic leader
Job Description: Job Responsibilities
1. Responsible for formulating the test plan and making changes to the plan according to the situation to ensure that the test plan and changes comply with relevant GLP/GCP regulations and the laboratory's SOP regulations. Before starting the test, ensure that the test plan is provided to quality assurance personnel and relevant test personnel.
2. Establish and verify the analysis method. Before the test, the contents of the test plan and test method should be explained in detail to the technical personnel participating in the test, the test procedures and precautions should be explained, the personnel participating in the test should be trained, and the entire test should be guided to follow the test plan. Request to proceed.
3. Responsible for ensuring that the instruments, equipment, and computerized systems used are confirmed or verified and in a suitable state, and for maintaining relevant instruments and equipment.
4. Responsible for the specific execution of the test process and ensuring that the test process complies with the specifications. Sign and date the original records of key steps related to the test, and accept inspection by quality assurance personnel.
5. Record and evaluate unanticipated deviations from the test plan during the test. With the approval of the person in charge of the institution, take corresponding measures, record the processing process, and provide a deviation evaluation report.
6. Organize and analyze test data results, write test reports, and ensure that the reports truly and completely reflect the original data.
7. Keep track of test progress and ensure timely, accurate and complete recording of original data.
8. After the test is completed, ensure that the test plan, original data, chromatograms, test reports, and other data related to the test are archived.
9. Make timely suggestions on revising and supplementing standard operating procedures.
10. Responsible for the coordination between various departments during the test and timely feedback on issues raised by quality assurance personnel.
job requirements:
1. 5 years of bachelor’s degree or more than 3 years of master’s degree in liquid chromatography-tandem mass spectrometry chemical drug clinical research or preclinical GLP bioanalysis; experience in large and medium-sized GLP/GCP bioanalytical CRO is preferred.
2. Proficient in the operation of liquid chromatography-tandem mass spectrometry (LC-MS/MS) equipment, and capable of analytical method development, methodology verification, and sample testing. Have management and coordination skills and the ability to independently undertake and complete projects.
Position Type: Biology Researcher
Work address: A6, Suzhou Biomedical Industrial Park, Huqiu District, Suzhou
Job Requirements
Experience and education: 1-3 years·Master's degree
Salary range: 10K-13K 12 months
Job keywords: GCPGLP