Senior Analyst, Microbiology and EM Lab, SRPL

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

• Over 8 years of GMP-related experience, with strong proficiency in microbial testing and aseptic techniques.
  GMP相关工作经验8年以上，熟悉微生物实验无菌操作。
• Performance of microbiological testing of product stream samples (excipients, bulk, packaging materials and finished products) to meet product release timelines.
  执行产品流样品（辅料、半成品、包材和成品）的微生物测试以满足产品放行计划。
• Performance of environmental and critical utility testing in accordance with Chinese GMP, EU GMP and cGMP regulations and Roche/Genentech standards.
  根据中国GMP，欧盟GMP，美国cGMP法规和罗氏/基因泰克的标准进行环境监控和关键设施的测试。
• Performance of microbiological testing of stability samples to meet stability program requirements.
  执行稳定性样品的微生物测试以满足稳定性研究计划的要求。
• Supporting manufacturing operations by timely completion of direct material sampling and ID testing.
  及时完成直接物料的取样及鉴别测试以支持生产运营。
• Continuous improvement of testing processes and technology, in collaboration with ASAT, to drive right first time and efficiencies.
  与ASAT合作，对流程和技术进行持续改进，提高一次成功率和工作效率。
  Qualification and validation of microbiological test methods.
  微生物测试方法的确认与验证。
• Supporting continuous improvement of manufacturing processes and technology, in collaboration with MSAT, by process validation and cleaning validation
  与MSAT合作，通过工艺验证和清洁验证支持生产工艺和技术的持续改进。
• Supporting investigations of microbial contamination in production processes, classified environments, and critical utility systems.
  支持在生产工艺、洁净环境和关键设施系统中发生的微生物污染的调查。

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.