Microbiologist: will be responsible for performing microbiology testing of raw materials, in-process samples, finished product, and environmental monitoring samples. He/she will work with microbiology personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with approved SOPs and regulatory requirements.



负责原辅料、中控样品、成品的微生物检测及环境监测。与微生物员工合作确保根据已批准的 SOP 和法规要求编写、维护、执行和批准测试结果、程序和方法






Responsibilities






Perform environmental monitoring following ISO 14644

依据ISO 14644 执行环境监测

Support microbiology laboratory operations

微生物实验室日常操作

Investigate and troubleshoot equipment, testing and process abnormalities

调查并解决日常操作中出现的仪器和实验异常问题

Perform microbiology testing for raw materials, in-process samples, and drug product

原辅料，中控样品和成品的微生物检测

Accurately document all necessary and relevant information in a clear and concise manner per cGMPs

根据cGMPs，以清晰简洁的方式准确记录所有必要和相关信息

Author, revise, and review standard operating procedures, test methods, work instructions, and protocols

编写、修订和审查标准操作程序、测试方法、工作说明和方案

Maintain clean, orderly, and safe laboratory work area

保持清洁、有序和安全的实验室工作区域

Assist in the development of microbiological laboratory testing procedures

协助起草微生物实验室相关检测程序

Identifies areas for improvement or gaps in both safety and compliance

识别工作中安全和合规性需要改进的方面

Effectively communicates issues/hurdles to supervisor and/or manager

有效地与主管/或经理沟通问题/障碍






Requirements



B.A./ B.S in Biology (or related) and 2–4 years of pharmaceutical experience

生物学(或相关)学士学位，2-4年制药工作经验

Knowledge of microbiological techniques (gram stain/microbial ID, aseptic, gowning, etc.)

熟悉微生物检测技术(革兰氏染色/微生物鉴定，无菌，更衣操作等)

Work in a team environment with well-developed interpersonal skills and excellent organizational skills

在团队中工作，具有良好的人际交往能力和组织能力

Self-starter and ability to work independently

积极主动，能够独立工作

Strong written/verbal communication and presentation skills

较强的书面/口头沟通和表达技巧

Working knowledge of microbial enumeration testing, environmental monitoring, bacterial endotoxin testing and sterility testing.

具备微生物计数检测，环境监测，内毒素和无菌检查能力

Working knowledge of cGMP, FDA, EMA, ICH, USP, and other regional and country specific guidance

熟悉cGMP, FDA, EMA, ICH, USP和其他地区和国家的相关指南