QC Analyst

Job Description Summary

Product quality review associated with the manufacturing process. Accountable for the quality of own work. Subject to direct operations supervision/prescribed work instructions/systems checking. Executes within a well-defined operations framework. There is generally a step by step sequence of standard operational tasks which need to be followed to achieve an end result.

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.

Job Description

PRIMARY FUNCTIONS:
职位职责

The 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 models and validation documents; translating methods.
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。

Perform all the QC sampling and analysis of e.g., utilities, raw materials, packaging materials, in-process samples, semi-finished/finished products and environmental monitoring.
完成所有QC取样和测试，例如，公用工程、原材料、包装材料、中间控制样品、半成品/成品，以及环境监控。

Accurately follow the current SOPs and analytical methods and participate in the writing of SOPs and analytical methods. Assist Lab Manager/Supervisor to ensure that all documents in QC Laboratory are current, accurate and comply with cGMP.
切实遵循现行SOP和分析方法并参与书写SOP和分析方法。协助实验室经理/主管确保QC实验室所有的文件都是现行的、正确的，并符合cGMP。

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.
确保所有原始测试数据被正确记录以及所有测试结果和实验调查被正确及时和完整地记录。

Participate in projects, validation works assigned by the Lab Manager/Supervisor.
参与由实验室经理/主管分配的项目和验证工作。

Be responsible for maintenance, calibration and upgrading of existing instruments and equipment.
负责对现有的设备和仪器的保养、校验和升级。

Be responsible for the reagent and consumable management in QC Laboratory.
负责QC实验室的试剂和耗材管理。

Fully trained and competent in cGMP requirements that are applicable to QC Laboratory.
接受完备的培训以胜任cGMP在QC实验室方面的要求。

Follow up own training program and train new employees in working methods.
跟进自己的培训计划并培训新员工。

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

QUALIFICATION/EXPERIENCE:
资质/经验

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

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

For Microbiology Laboratory: Experience of aseptic technique is desirable.
针对微生物实验室：有无菌操作技能。

Knowledge of MS office software is required.
了解MS办公软件。

Basic English knowledge is required.
具备英语技能。

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.

Additional Information