QC微生物研究员
Description
教育程度/经验Education background/ Experience
微生物学、药学、生物工程相关专业专科及以上；其中专科需有五年微生物相关工作经验；本科需有两年微生物相关工作经验；
Associate degree or above in Microbiology, Pharmacy, Bioengineering, or a related field; at least five years of microbiology-related experience for associate degree holders and two years for bachelor’s degree holders.
了解相关法规指南和质量风险评估策略，有EM超限调查及趋势分析报告，变更，风险评估报告等起草经验。
Knowledge of relevant regulatory guidelines and quality risk assessment strategies, with experience in drafting EM excursion investigations, trend analyses, change controls, and risk assessments.
精通环境监测/工艺气体分配系统监测/制药用水监测的相关取样及检测操作。
Proficient in sampling and testing for environmental monitoring, process gas distribution systems, and pharmaceutical water systems.
掌握相关仪器设备工作原理、设备系统适用性及日常校准的原理。
Good understanding of relevant instrument/equipment principles, system suitability, and routine calibration.
了解洁净室/工艺气体分配系统/制药用水系统的验证要求。
Knowledge of validation requirements for cleanrooms, process gas distribution systems, and pharmaceutical water systems.
其他要求（比如工作时间或特殊技能等）Other requirements (e.g.: working time, special skills)
责任心强、敬业，并具有较强的主人翁意识。
Responsible and dedicated, with a strong sense of ownership.
具备较强的抗压能力和积极的工作态度
Strong stress tolerance and a positive attitude.
具备良好的跨部门沟通能力和清晰的逻辑思维。
Strong cross-functional communication skills and clear logical thinking.
有良好的英文能力会被优先考虑
Candidates with strong English proficiency will be given preference.
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2. 工作职责JOB RESPONSIBILITY
负责微生物相关的检测，包括但不限于： EM取样，人员卫生表面取样, 水检测、气体检测等以及与水检测、气体检测、EM取样相关仪器设备的规范操作与使用。
Perform microbiological testing activities, including but not limited to EM sampling, personnel hygiene/surface sampling, water testing, and gas testing, as well as the proper operation of related instruments and equipment.
负责微生物组文件相关工作，包括但不限于各种检测方案、趋势分析报告、变更文件。超限调查等。
Responsible for drafting and maintaining microbiology-related documentation, including but not limited to testing protocols, trend analysis reports, change control documents, and excursion investigation reports.