Microbiological Examiner

Job Responsibilities:

1. Inspection of incoming goods and finished products

1. Carry out microbial limit test, particle test, etc. on raw and auxiliary materials in accordance with the inspection procedures, and fill in the inspection records and other related records in a timely manner;

2. Carry out initial contamination bacteria inspection, sterility inspection, and bacterial endotoxin inspection on products according to inspection procedures, and fill in inspection records and other relevant records in a timely manner;

3. Participate in the verification of product microorganisms;

2. Environmental monitoring

1. Detect the environment of the clean area in accordance with the inspection procedures, including the detection of settled bacteria, wind speed and ventilation times, dust particle detection, pressure difference detection, temperature and humidity detection, and fill in relevant records in a timely manner;

2. Detect microorganisms on the hands and surfaces of objects in the clean area in accordance with the inspection procedures, and fill in relevant records in a timely manner;

3. Public system

Test the purified water system and process gas system in accordance with the inspection procedures, and fill in the relevant records in a timely manner;

4. Other work

1. Participate in the drafting of relevant inspection documents;

2. Purchasing and preparing standard products, reagents, culture medium, etc. according to relevant documents;

3. Use, clean and maintain inspection instruments, equipment and measuring instruments in accordance with relevant documents;

4. Clean and disinfect the laboratory, clean room environment and facilities in accordance with the laboratory management system;

5. Collect inspection and testing data and data, analyze and evaluate;

6. Report to the higher-level leaders when abnormal situations are found;

7. Assist other departments and undertake other tasks assigned by leaders.

 

Job requirements:

1. Bachelor degree or above, major in biology, microbiology, and medicine;

2. Familiar with relevant laws and regulations of medical devices, familiar with quality control related work, proficient in microbial limit, sterility and other inspection operations;

3. Strong sense of responsibility, strong learning ability, willing to accompany the company's long-term development.

Working place: Zhongguancun Medical Device Industrial Park, Daxing District, Beijing. Interested parties please send your resume to: rwang@ametcorp.com