Johnson & Johnson Careers

QC Micro Associate Manager

Hangzhou, China
Quality Control


Job Description

Requisition ID: 1805642722W

  1. Lead and manage the Micro team for the execution of the microbiological assays aforementioned (sterility, B&F, Bioburden, Microbial Limits, AME/PET testing, etc…).
    领导并管理微生物团队进行所述的微生物测试(无菌, B&F, 生物负载, 微生物限度, AME/PET测试等)。
  2. Provide expertise support on site Sterilization Assurance including training, risk assessment, industry and regulation trends,validation, aseptic process and environment, procedure establishment and execution, exceptional event investigation and corrective action evaluation, etc.
在以下几方面为工厂无菌保障提供专业支持,包括培训,风险评估,法规趋势,验证,无菌工艺及其环境,程序建立和执行;异常情况调查和整改措施评价等。
  1. Review and optimization of batch records, SOP, non-conformance/OOS investigation, CAPA, micro certifications, EM assessment.
    审核和优化批记录, SOP, 偏差/OOS调查, CAPA, 微生物证书, 环境评价等。
  1. Change control and validation (review).
    变更控制和验证(审核)。
  1. The Microbiology associate manager may have some involvement with data and metric management, project management, audits, and technical and regulatory assessments.   This person will participate with investigations within the microbiology department and will assist with audits, regulatory assessments, and product complaint investigations/product impact analysis.
    微生物副经理可能还涉及数据和度量管理, 项目管理, 审计和技术以及法规评估工作。参与微生物部门的调查, 并为审计, 法规评估和产品投诉调查/产品影响分析。
  1. Perform management responsibilities associated with development, coaching, and mentoring of direct reports, as well as the performance evaluation of direct reports.
    实施向其直接汇报人员的发展,指导和监督等相关管理职能, 也包括这些人员的绩效评估报告
    1. Perform other management responsibilities such as the development and management of the area budget.
      执行其它管理职责, 比如微生物实验室的预算建立和管理

Qualifications
学历与经验
EDUCATION ADN EXPERIENCE
  1. Required: Bachelor Degree with over 5 years of experience, Master’s Degree with 3-4 years of experience, or Doctor Degree with 1 to 2 years of experience.  The degree must be in Microbiology or a closely related field
    要求:本科毕业并有6-7年工作经验
              研究生毕业并有3-4年工作经验
              博士毕业并有2年工作经验
              必须是微生物或相近专业背景
  2. Desired: Over 5 years’ experience or more of related Quality laboratory, preferably Microbiology, Effectively managing organizational effectiveness and communication mechanisms.
    最好具有5年或更多的在相关质量实验室工作经验, 微生物实验室为佳, 有效管理实验室的效率和沟通机制,
  3. Desired: Experience in ISO13485,11137,11135, US 21CFR 210, 211, 820
    最好具有相关法规( ISO13485,11137,11135, US 21CFR 210, 211, 820 )经验, 
  4. Trained and experienced Microbiologist: Strong proficiency and mastery of environmental control programs for aseptic pharmaceutical or biopharmaceutical commercial manufacturing.  Ability to train, mentor and develop others in the technical areas of microbiology.  Ability to be a strong role model.
    受过良好培训和具有经验的微生物人员:对于无菌药品或生物药品商业生产中的环境控制非常熟悉。 在微生物技术领域具有培训, 指导和发展他人的能力。能够成为好的行为榜样。
     
     
    必备技能
    ESSENTIAL SKILLS AND ABILITIES
    Technical:
    Knowledge of fundamentals of biopharmaceutical or pharmaceutical manufacturing, aseptic filling and associated microbiological techniques, methods and regulatory requirements.  Knowledge in the areas of Microbial Limits, Sterility, Endotoxin, Anti-Microbial Effectiveness and Preservative Effectiveness testing; Knowledge in establishing and maintaining an EM, Water sampling and testing program.  The knowledge of environmental monitoring program should include but not be limited to design, applications and management in the biotechnology, biopharmaceutical or pharmaceutical fields.  Knowledgeable of traditional microbial ID methods and strong supporter of rapid microbial methods; cGMP experience of data evaluation trending and troubleshooting.  Strong proficiency in investigational skills for root cause analysis and microbiological methods validation experience.

    技术:
    生物制药或药品生产制造,无菌灌装和相关的微生物技术,方法和法规要求的基础知识。在微生物限度,无菌,内毒素,抗微生物效果和防腐剂效果测试等各领域的知识。 建立和维持一个环境监控,水系统取样和测试计划的知识。环境监测方案知识应包括但不限于设计,应用和在生物技术,生物制药及医药领域的管理。传统的微生物鉴别方法和快速微生物测试方法的知识。数据趋势评估和偏差处理得cGMP的经验。具有根本原因分析技能和微生物方法验证经验。

Primary Location
China-Zhejiang-Hangzhou
Organization
AMO (Hangzhou) Co., Ltd. (7077)
Job Function
Quality Control
Requisition ID
1805642722W