Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Xian, Shaanxi, China

Job Description:

• 严格依据质量标准/检验方法及实验室的各项管理规范及时准确地完成对原料、辅料、包材及其他化学检验物料样品等的检验工作；
• 严格依据质量标准/检验方法及实验室的各项管理规范及时准确地完成对产品、稳定性样品及其他化学检验产品样品等的检验工作；
• 确保数据完整性；Ensure data integrity of laboratory;
• 正确操作及维护实验室日常设备；
• 正确操作实验室相关软件：如eLIMS, SQC等；
• 实验室其他相关工作：如卫生区域维护，台账管理等；
• 了解所有与职位相关的J&J的安全、环境、工业卫生规范，在工作过程中严格执行并遵守；
• 人员培训工作；Training the analysts;
• 复核检验记录，报告，质量标准，检验方法等相关文件；
• 对QI,OOT/OOS等事件进行调查；Investigation of QI/OOT/OOS and other laboratory issues;
• 负责实验室相关变更，纠正预防措施等；Responsible for laboratory COC, CAPA, etc.;
• 负责实验室相关文件的起草，升版及相关系统更新维护申请；
• 完成化学检验方法的验证/确认/传送；
• 及时发现并解决实验室相关问题；
• 熟悉精麻法规确保日常操作符合特殊药品安全管理制度及相关文件要求。

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, ISO 9001, Persistence and Tenacity, Quality Control (QC), Quality Control Testing, Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technologically Savvy