QC微生物分析员

根据岗位需要，至少负责以下1项及以上工作内容：

Based on the

of the job, at least one of the responsibility should be matched:

1. 负责洁净区环境监测取样；负责工艺用水（注射水、纯化水、纯蒸汽）取样及其理化检测；负责工艺气体监测，以及趋势报告的起草。 Responsible for environmental monitoring, process water (WFI, PW, Pure Steam) sampling and physical and chemical testing, monitoring process gas system, and drafting trending reports.

2. 负责起草、升版微生物检测相关的SOP以及方法验证，负责原辅料、中间品、成品等微生物相关的检测任务，包括但不限于Bioburden test, Endotoxin test, Sterility test. Responsible for drafting and updating SOP of microbiology testing method and method validation, responsible for performing testing task of raw material, DS, DP, including but not limit Bioburden test, Endotoxin test, Sterility test, CCIT test.

3. 负责菌种的分离纯化，保藏；熟悉基因鉴定、MALDI-TOF等微生物鉴定方法相关的背景知识。 Responsible for strain purification and strain preservation, acquainted with the background acknowledge of microbiology identification such as ID and MALDI-TOF.

4. 负责灭菌工艺的验证以及清洁验证。 Responsible for validation of sterilization process and cleaning validation.

5. 配合实施实验室仪器设备的确认验证、使用、清洁、维护和校验，确保仪器的有效运行与管理。负责实验室调查、变更，CAPA行动项的执行。 Cooperate to implement equipment, and calibration, utilization, clearance, maintenance, and calibration, and ensure effective operation and management of them. Responsible for laboratory investigation, change, and performing the action of CAPA. 6. 负责微生物检测OOS的实验室调查，负责变更，偏差的起草。 Responsible for OOS lab investigation, drafting change control and deviation.

岗位要求

教育程度/经验Education background/ Experience Bachelor or Master degree in Microbiology, Biochemistry, Food Science, Pharmaceutical Science, or other related field. Extensive experience in microbial testing, environmental monitoring, aseptic assurance or aseptic processing.

特别知识Special knowledge Knowledge and expertise in at least one of the following fields: Microbiology Environmental monitoring techniques including monitoring for viable and non-viable particles Utility monitoring techniques including physicochemical and microbiological testing

技能Skills Fluent in writing and reading in both Chinese and English. Good computer operation skill (Microsoft Word, Excel, PowerPoint, Visio etc.)

其他要求（比如工作时间等）Other requirements (e.g.: working time) Stress tolerance, positive attitude, and problem-solving skills in difficult situations. Strong cross functional communication skills and clear logical thinking. Responsible and dedicated, with a strong sense of ownership.