(Sr/Expert) Technician-QA-EM

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.

工作部门Function:

QA/QC-Quality Control-Environmental Monitoring

主要职能Key Responsibilities:

• 正确遵守HSE规程，在日常工作中正确穿戴PPE。Apply HSE procedures correctly and correctly wear the expected PPE 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.
• 正确遵守分级区的微生物和粒子监测的规程，执行环境监测取样操作，包括尘埃粒子监测，浮游菌，沉降菌和表面取样，以及人员监测。Following the current procedures for microbiological and particle sampling of classified areas, and perform environmental monitoring sampling, including non-viable, viable, surface sampling and personnel monitoring.
• 正确遵守洁净系统监测规程，执行洁净系统质量监测，包括饮用水，纯化水，注射用水，洁净蒸汽和洁净压缩空气系统。
  Following the current procedures for utility monitoring, and perform quality monitoring clean utility systems, including portable water system, purified water system, water for injection system, clean steam system and pharmaceutical compressed air system.
• 执行环境监控样品和洁净压缩空气样品的培养、读数等样品处理。将数据结果和规程中定义的限度进行比对，遇到超限度，趋势，异常结果，进行汇报。Perform incubation, reading and other sample processing activities for environmental monitoring and pharmaceutical compressed air samples. Check that the results are in line with the recorded limits in the reference procedures, notifying any out-of-action, trends and atypical analytical results.
• 使用电子系统或纸质文件确保监测数据完整有效。
  Using electronic system or paper documents, ensure complete and effective monitoring data.
• 确保所需物料和设备满足日常运营需求。Maintain inventory of materials and equipment available for sampling needs.
• 参加环境监测性能确认的执行。Participate in Environmental Monitoring Performance Qualification (EMPQ) execution.
• 协助无菌保证和EM/FUME不合格原因调查。
  Assist root cause investigation of Sterility Assurance and EM/FUME non-conformances.
• 保持开放的沟通环境，加强团队合作，加强跨部门的员工合作和沟通。
  Maintain open communications and promote teamwork and employee participation and communicate in the work group with other department.

基本要求 Basic Requirements:

• 按时完成岗位相关的资质认定计划。
  On time complete duty related personnel qualification programs.
• 主管安排的其他任务Other jobs assigned by supervisor
• 可参与倒班。Able to participate in shifts.
• 能够读懂、听懂英文可以进行简单书面和口头表达
  Able to read and speak simple English
• 需要加班时要加班。工作需要的紧急情况需能够及时反应。
  Ability to work overtime as required. Available off shift to respond to operational issues.

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