Johnson & Johnson Careers

QC Chemistry Analyst

Hangzhou, Zhejiang
Chemistry


Job Description

Requisition ID: 1805665390W

  1. 日常检验及复核工作:按计划按时准确完成原辅料、成品、稳定性样品、中控样品、投诉样的检测任务。按时完成原始记录复核工作,确保记录符合GMP、GLP要求。
Routine testing and reviewing work: Perform testing for raw materials, final products, stability samples, bulk samples and complaint samples within required testing cycle time. Review raw data in time and make sure that the record meets GMP and GLP compliance requirements.
  1. 协助主管或高级分析师调查OOS/ER并找到根本原因。在高级分析师或主管的协助下完成变更申请的相应行动计划。
Assist Supervisor or Senior Analyst to perform the OOS/ER investigation to find out the root cause. Complete the related action plan in the Change Request with guidance of Supervisor or Senior Analyst.
  1. 针对当前实际操作流程撰写合规的SOP/WI,并对员工进行培训指导。
Write compliant SOP/WI according to the actual operation process and guide employees.
  1. 验证工作:按照草案或者程序要求完成实验室新方法的确认工作。
Method qualification: Fulfill the new method qualification according to approved protocols or procedure.
  1. 技术支持:能提供相应化学分析相关的技术支持。
Technical support: Provide relevant technical support about chemical analysis.
  1. 法规遵循:遵循ISO13485, GMP,QSR820, 21CFRPart 211 及公司政策,符合规定的要求。
Regulation compliance: Comply with the requirements of ISO13485, GMP, QSR820, 21CFRPart 211 and company regulation.
  1. 其他:执行其它工作任务, 例如团队的紧急任务。
Others: Perform other working tasks, such as the urgent task of the team.

Qualifications
EDUCATION ADN EXPERIENCE
学历与经验
药学,药物分析,分析化学或相关专业,大专及以上学历。
Pharmacy, pharmaceutical analysis, analytical chemistry or related major, junior college degree or above.
至少2年医药或医疗器械跨国公司化学实验室工作经验,熟练掌握GMP及GLP知识,或者知名大学本科或研究生应届毕业生。
At least two years related experience in the chemical lab of medicinal or medical devices international company and command knowledge of GMP and GLP, or the graduating student from famous university with Bachelor or Master Degree.
 
ESSENTIAL SKILLS AND ABILITIES
必备技能
 
  1. 良好的人际沟通能力,正直诚信,关注细节。
    Good communication and interpersonal skills, Integrity and ethics and detail oriented.
  2. 良好的英语阅读能力,具备书写能力者佳。
    Ability to read and write English preferred.
  3. 能够娴熟的使用Windows及office办公软件
    Computer operation skill is well, such as practice in Excel, Word and PowerPoint.

Primary Location
China-Zhejiang-Hangzhou
Organization
AMO (Hangzhou) Co., Ltd. (7077)
Job Function
Chemistry
Requisition ID
1805665390W