QC Senior Analyst

Job Description Summary

Product quality review associated with the manufacturing process. Impacts quality of own work and the work of others on the team. Executes standard operational/technical tasks typically subject to instructions and work routines. There is latitude to rearrange the sequence to complete task/duties based on changing work situations.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

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Job Description

角色与职责

The Senior QC Analyst will be responsible for performing and reporting of routine analytical tests in the QC Laboratory according to the specifications; drafting/revising/reviewing SOPs, methods, specifications, training modules and validation documents; translating methods; training new analyst and following up the corresponding analyst’s work in the QC Laboratory.
高级QC分析员的职责是根据质量标准进行和报告QC实验室的常规分析测试； 起草/修改/审阅标准操作规程 (SOP)﹑方法﹑质量标准﹑培训讲义和验证文件； 翻译方法；培训新的分析员及跟进QC实验室内分析员的工作。

Responsible for both performance and arranging tasks of all the QC sampling and testing of e.g., utilities, raw materials, packaging materials, in-process and semi-finished/finished products, and environmental monitoring as well.
负责完成并安排所有QC取样和测试，例如，公用工程，原料，包装材料，中间样品，半成品、成品以及环境监控。

Be responsible for both performance and organizing the maintenance, calibration and upgrading of existing instrument and equipment.
负责完成和组织对现有的设备和仪器的保养、校验和升级。

Participate in new global/local projects and take part in the validation work throughout the plant, in which QC resources are required. Complete required validation documentations.
参与有QC资源需求的全球/本地的新项目，以及验证工作。完成所需验证文件。

Ensure that all the raw data during the testing are correctly recorded down and all results or testing investigation summary are made completely and timely. Ensure all the records including journals, files and LIMS entry are checked and approved.
确保所有原始测试数据被正确记录，所有结果或测试调查总结能完整并及时地完成。确保所有记录包括记录本、原始数据文件和LIMS录入被复核和批准。

Assist Lab Manager/Supervisor to ensure that operating in QC Lab is in compliance with cGMP or relevant regulations/guidelines, GEH/Corporate quality/safety standard, in terms of documentation, sampling and testing.
协助实验室经理/主管确保QC实验室在文档、取样和测试方面按照cGMP或相关法规条例、GEH/公司总部质量和安全标准进行运作。

Be able to finish the task arranged and required by Lab Manager/Supervisor.
能按照实验室经理/主管的要求和安排完成工作。

Ensure that corporate and local EHS procedures are followed.
确保遵循总部和本公司EHS规程。

基本资格

Relevant Scientific College graduated or above is essential.
相关的理工科大专毕业及以上学历。

Experience from pharmaceutical quality control laboratories and basic knowledge of GMP is desirable.
具备制药业质量控制实验室经验和GMP知识。

Knowledge fundamentals of analytical technology is desirable.
有分析技术的知识基础。

A good knowledge of computer and English is desirable.
有良好的计算机和英语技能。

所需特性

优秀的口头和书面沟通能力。优秀的人际关系和领导能力。能够独立工作。较强的解决问题能力。

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.