ROLE AT A GLANCE:
Test the raw material, bulk products, finished product, uniformity testing, validation testing and other related testing according to relevant specification.
HOW YOU’LL MAKE AN IMPACT: *list top 5-8 core responsibilities and tasks
- 依据QC分析方法，进行相关的理化检测。及时记录并保留原始数据。Performs appropriate chemical and physical tests as required by QC analytical method, and record all the test parameter and data on paper after test at once, keep all of the original records for analysis report.
- 对于日常分析工作，半成品或成品检测应符合生产及成品发运计划要求。原料及稳定性样品一般应在LIMS登记后7个工作日/30日历天内完成或符合生产计划及产品开发要求。In routine work, analyst must finish test report of finish goods and in process samples according to production or shipping plan; and test report of raw materials and stability test samples in 7 workdays / 30 days normally or within the requirement of production plan and new product development plan.
- 检验原始数据应清晰、准确。计算准确、结果精确。Responsible for getting accurate result in special test period, original record and calculation should be written clearly and accurately.
- 熟练使用实验仪器，及时判断并解决理化检测中的常见问题，并给予同事工作上的指导。Using general chemical instruments in chemical Lab, and resolve routine problems in chemical or physical test by himself/herself, and give help to other analyst.
- 依据QC标准规程，配置并使用标准品、标准溶液、标准滴定溶液、质量控制样品、试剂、溶液及指示剂。及时完成配置及使用记录，并合理归档，以供追溯。Handling and using of reference standards, reference standard solutions, volumetric solutions, control samples, reagents, indicators and solutions according to relevant QC SOPs. Record of preparation and using must be written immediately and keep them in special place.
- 完成指定仪器 （如HPLC，GC，ICP，ICP-MS，微波消解仪）的日常维护和检查，如月度检查。及时订购特有的耗品、耗件，防止因短缺而影响检测。Responsible for check special equipment monthly, find and order any parts of shortage of special equipment at once.
- 接受检测方法、SOP、GMP培训。遵守SOP规范和ISO/IEC 17025准则。经指定，需及时完成新SOP起草或SOP更新。Responsible for accepting training of technique and SOPs and GMP, and doing anything as required by SOPs & ISO/IEC 17025. Analyst should in charge of drafting new SOPs and modify old SOPs when any changes happened.
- 保持实验室安全及实验台面整洁。检测时，应严格遵守检测方法、安全操作要求和化学品安全准则，在任何时间避免物理、化学伤害。对于水电气应具有常规使用和安全知识。下班前应做好安全检查。Responsible for cleaning and safety in chemical Lab. Chemical analyst should keep cleaning his work area after analysis. During analysis, analyst must use adequate method avoid chemical or physical hurt all the time. After workday, any analyst should care about city water, electric switch, stream and others related to safety.
- 对于任何实验室OOS结果，应及时通知实验室组长或经理。协助完成OOS调查，并在7个工作日内完成调查报告。
When the result out of specification, analyst should be responsible for investigation of discrepant result with Chemical Lab leader or Lab manger, and finish the final report in 7 workdays.
- 参与新化学检测方法验证，并在验证计划要求时限内完成验证报告，验证过程符合验证大纲要求。Responsible for validation of new chemical method, and finish report in validation plan. Take part in validation of process, and finish test report in special test period as required by protocol.
- Additional duties as assigned.
TEAM DYNAMICS:
- Interact with QC team and QA engineer, QA Manager, new products developing team members and other departments including Shanghai Operation department. Interact with purchased relevant persons and warehouse men.
