(Sr./Expert/Sr. Expert) Technician-QC Biological

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

参与微生物实验室的测试，并确保监测和测试操作符合中国 GMP和礼来 GQS的要求。 Participate in microbiological lab tests, meanwhile ensure the monitoring and the test operations are complied with both Chinese GMP and Lilly GQS requirements.

• 正确遵守HSE规程，在日常工作中正确穿戴PPE。 Apply HSE Procedure correctly and wear the expected PPE correctly during work.

• 在日常工作中正确遵守数据完整性要求。 Apply Data Integrity requirement correctly during work.

• 积极主动在团队内和团队外分享质量和安全相关的事项。 Share event on quality and HSE inside and outside team actively.

• *执行微生物实验室的放行测试，包括但不限于：水系统，中控样品，原辅料，包材，稳定性和成品。 Perform QC microbiological lab release testing, including but not limited to: Utility, IPC, Excipients, PPC, Stability and Drug product.

• 协助微生物实验室相关的方法确认和研究（包括起草方案，执行，撰写验证报告）。 To assist with method verification and study for microbiological lab test (including protocol draft, method verification execution, report generating).

• *负责起草/修订微生物测试相关的WI和SOP。 Be responsible for the WI and SOP draft/revision in QC microbiological lab.

• 参与微生物洁净室的管理。 Participate in microbiological lab clean room management.

• 参与微生物测试相关的消耗品，试剂以及全球/本地标准品进行管理。 Participate in management of consumables, reagents, and global /local standards which related to microbiological lab test.

• 参与微生物实验室的文件管理。 Participate in document management for microbiological lab.

• 参与微生物实验室的5S管理。 Participate in 5S management for microbiological lab.

• 做其它和质量有关的事项。 To assume other tasks related to Quality.

• 协助GLIMS系统实施。 To assist with GLIMS deployment.

• 协助实验室质量体系的持续改进提高和 GLIMS系统实施 To assist with lab quality system continuously improvement and GLIMS deployment.

• *负责稳定性样品的接收和取样（可选） Responsible for the receiving and sampling of stability samples.

• 负责实验室日常报告的第二人复核 （可选） To be responsible for the routine lab reports second person verification.

• 负责实验室新进人员的培训 （可选） Responsible for fresh analysts’ training.

• 大专及以上学历，药学生物学或相关学科。 College degree or above, majored in pharmaceuticals, biological or related sciences.

• 能用英语写和读。 Capable of writing and read in English.

• 根据实验室运营需要，能够接受早班、中班及周末轮班安排。 Ability to work morning shifts, afternoon shifts, and weekend rotations based on laboratory operational requirements.

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