岗位描述：
1. Professionaland timely completion of the serological and NAT analytics (Plasma samples,Plasma Pool and Products) for Plasma Collection, Quality Management and Manufacturing.
及时为血源、质量管理、生产部门提供专业的血清学和核酸检测结果分析（包括原料血浆、合并血浆及成品）
2. Assist the Specialist to complete sample and retention sample management to ensure that the samples received meet experimental and regulatory requirements.
协助专员完成样本及留样的管理，确保所接收的样本满足实验及法规要求。
3. Obey the work arrangement, complete the experiment timely, accurately and in compliance and issue the report and complete quality control statistics, And ensure the integrity and compliance of the generated testing data.
服从工作安排，及时、准确、合规的完成实验并出具报告及完成质控数据统计，并确保产生的检验数据的完整性及合规性。
4. Production, receive , plan and control of reagents, test-kits, reference material, standards, etc. Responsible for confirmation of kits and quality control products, And ensure that the received experimental consumables meet the usage requirements.
制备、计划、接收和管理试剂盒、对照品和标准品等，负责各自实验用试剂盒及质控品的确认，并确保所接收的实验耗材符合实验要求。
5. Timely maintenance (service/cleaning), calibration and monitoring of the divisional equipment and infrastructure，Timely Maintain laboratory environment and dispose medical waste.
及时对小组使用的仪器设备和基础设施进行维护（保养和清洁）、校准和检查，及时维护实验环境和处理医疗废物。
6. Timely notification of OOx results and deviations to line manager, Assist lab specialist to complete OOX and deviation investigation. Support investigation process, including root cause analysis.
及时将OOx的实验结果和偏差通知到实验室负责人，并协助实验专员完成OOX及偏差调查，支持调查过程，包括根本原因分析。
7. Adheres strictly to all instructions and procedures including good documentation practice, support to improve lab record documentation and process.
严格执行包含文档管理规范在内的所有操作流程，并协助改进实验室记录文档及流程。
8. Supports the timely generation and editing of the divisionally owned SOP’s.
支持小组内操作规程（SOP）的编写与修订。
9. Collaboration in resolution of associated virus problems or questions，Complete temporary task assigned by line manager.
协同其他部门解决检测涉及病毒相关的技术问题或疑问，并完成直线经理临时分配的其它任务。
10. Supports implementation of divisional change control, CAPA etc..
支持小组内变更、CAPA等的实施。
11. Supports qualification and validation of plasma testing methods.
支持确认、验证血源检测的实验方法。
12. Supports equipment qualification of divisional equipment.
支持小组内仪器设备确认。
13. Personal further development (courses, literature study etc.) .Participated in and completed CSL manufactory and department training and related skills assessment, and successfully passed.
重视自身发展（参加培训、学习文献等）。参加并完成CSL工厂及部门的培训及相关技能考核，并顺利通过。
14. Completed the annual inter-laboratory ability assessment and passed it successfully.
完成年度实验室间能力考核，并顺利通过。
任职要求：
1. Junior college degree or above in clinical medicine, pharmacy or bioengineering.
临床医学、药学及生物工程相关专业大专及以上学历。
2. Understanding of GMP, particularly Appendix Ⅳ blood products. Sound knowledge of industry guidance documents and standards.Biochemical analytics in a medical or pharmaceutical GMP regulated environment.
了解GMP，特别是附录四血液制品。熟悉行业指导文件和标准。具备在符合GMP规定的医疗或制药环境下进行生物化学分析的能力。
3. Strong working knowledge of GMP requirements.
对GMP要求有较强的工作知识 。
4. Good communication and problem-solving skills.
良好的沟通和解决问题的能力。
5. Ability to work independently and as part of a team.
能够独立工作，并能融入团队 。
6. Flexible and adaptable approach.
灵活性和适应性强。
7. Strong dedication to the job combined with a willingness for self-development.
有很强的事业心和自我发展的意愿。