Johnson & Johnson Careers

Senior QA Technician

Suzhou, China
Quality Control


Job Description

Requisition ID: 1905722258W

Product Quality, Control & Disposition and Performance Standards:
  1. Accountability and ownership for semi-FG, FG, & Raw Material Review, as well as material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
  2. Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
  3. Conduct investigation, bounding, documentation, review and approval of NCs, CAPAs and customer complaints. Escalation of quality issues as appropriate.
  4. Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
  5. Support IQ, OQ, PQ, TMV or Software Validation
产品质量,控制和处置以及性能标准:
1.负责SFG,FG和原材料审查,以及材料识别,材料隔离,缺陷类型分类,包括在制造中日常应用这些技术。
2.收集数据并执行/进行各种分析/统计分析和解释,作为流程改进和日常支持的一部分。
3.对NC,CAPA和客户投诉进行调查,限制,记录,审查和批准,以及必要情况下的升级质量问题。
4.分析/审查预防和纠正措施的有效性。 根据既定流程审查根本原因调查。
5.支持IQ,OQ,PQ,TMV或软件验证
Compliance/Regulatory
  1. Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the China GMP, ISO 13485, etc.
  2. Support internal and external audits.
  3. Support periodic line audits to assess for production controls. Review results of area audits to ensure that corrective and preventive actions are adequate.
合规/监管
1.审查/分析当前的产品和流程(包括所采取的行动或决策)是否符合中国GMP,ISO 13485等标准。
2.支持内部和外部审计。
3.支持定期审核以评估生产控制。 审查区域审核的结果,以确保纠正和预防措施是充分的。

Qualifications
  1. Good communication skills in both Chinese & English
  2. Mechanical drawing interpretation
  3. Statistical analysis tools
  4. GMP background is preferred.
1.良好的中英文沟通能力
2.机械制图阅读能力
3.统计分析工具
4.最好有GMP经验

Primary Location
China-Anhui-Suzhou-No. 299, Changyang Street, Suzhou Industrial Park
Organization
Johnson & Johnson Medical Suzhou Ltd. (7054)
Job Function
Quality Control
Requisition ID
1905722258W