Quality Control Microbiology Supervisor

Johnson & Johnson

4.2

Hangzhou, China

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020

  • 4.2/5 in overall job satisfaction

  • 4.3/5 in supportive management

  • 72% say women are treated fairly and equally to men

  • 88% would recommend this company to other women

  • 85% say the CEO supports gender diversity

  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).

  • Global exercise reimbursement.

  • Two weeks off (one of them fully paid) for volunteer work.

  • #2306109647W

    Position summary

    1.  领导并管理微生物团队进行相关微生物测试(无菌,GPT, 生物负载, 微生物限度, AME/PET测试等)。
      Lead and manage the Micro team for the execution of the microbiological testing (Sterility, GPT, Bio-burden, )Microbial Limits, AME/PET testing, etc...)
    2.  负责调查超限/OOS/NC 并找到根本原因;负责CAPA的发起及相应的行动项的跟进。做到及时、准确,逻辑清晰、能够提供行之有效的纠正预防措施。负责相关变更的发起、追踪与关闭。
      Be responsible for the Excursion/OOS/NC investigation to find out the root cause; Be responsible for the CAPA initiation and related activities follow up. Ensure the investigation performance detailed and specific with logistic, as well as the CAPA effective. Be responsible for related Change Request initiation, tracking and closure. 
    3.  负责培养基模拟灌装过程的监督检查,以及负责培养基灌装产品无菌性检查的指导和监督。
      Be responsible for media fill simulation process inspection, and also be responsible for guiding and inspecting the media fill products' sterility check.  
    4.  根据实验室检测需求,协助经理制定培训发展计划,并对新员工进行检验技术培训,使其实际操作技能符合GMP/EHS要求。
      Assist manager to make the training plan for laboratory employees according to testing needs, perform the technical coach for new employees and make sure that the operation skills of new employees comply with GMP/EHS requirements.
    5.  负责微生物实验室各项验证工作,包括仪器验证、方法验证、方法适用性确认、消毒剂验证等。
      Be responsible for the validation in micro lab, such as equipment validation, method validation, method suitability verification, disinfectant validation etc.
    6.  负责微生物实验室相关评估,按照规定时间完成相应的评估提出建议行动计划,如药典更新后的评估,法规更新后评估及总部程序更新后本地程序的评估等。
      Be responsible for related assessment in micro lab, completed the assessment and suggest the action plans accordingly, e.g. assessment for Pharmacopoeia revision, assessment for regulation update and assessment for local procedure according to global procedure update.
    7.  负责微生物实验室的卓越运营和持续改进工作;优化微生物实验室的工作流程;改善微生物实验室工作效率。
      In charge of micro lab operation excellence and continuous improvement; optimize lab workflow; improve lab working efficiency.
    8.  负责微生物实验室的EHS工作,严格遵循强生EHS政策,落实《安全生产法》及相关法规所要求的岗位安全责任,遵守本单位的安全生产规章制度和操作规程,正确佩戴和使用劳动防护用品,接受安全生产教育和培训,持续改进EHS工作流程,发现上报消除潜在隐患。
      In charge of micro lab EHS&S management. Follow up JNJ policy of EHS strictly, as well as Production Safety Law and relevant local regulations on the post safety responsibilities. Follow up procedures and work instruction, correctly use PPE and participate training. Contribute to continuous improvement the EHS working process of QC to eliminate potential risk.
    9.  遵循ISO13485,GMP,21CFRPart 820,21CFRPart 211及公司政策,符合规定的要求,协助经理进行各种审计准备。
      Comply with the requirements of ISO13485, GMP, 21CFRPart 820, 21CFRPart 211 and company regulation, assist manager in audit preparation.
    10.  执行其它管理职责,如部门预算建立,财务数据的统计,项目相关费用和工时的统计以及部门培训协调等
      Perform other management responsibilities such as lab budget establishment, financial data statistics, project related expense & labor hours statistics and training coordinate etc.
    11.  对直接汇报的下属人员履行管理职责;包括这些人员的绩效评估,人员发展,以及相关的培训、监督和指导。
      Executing management responsibilities for the direct report staffs, including performance review and talent development, associated with training, monitoring, coaching for these direct report staffs.
    12.  其他:执行其它工作任务,例如团队的紧急任务。

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    What are Johnson & Johnson perks and benefits

    Child care benefits

    Paid maternity

    Unpaid maternity

    Paid paternity

    Unpaid paternity

    Paid adoptive

    Short term disability

    About the company

    Industry: Consumer Packaged Goods: Packaged Products
    By caring for the world one person at a time, we aspire to help billions of people live longer, healthier, happier lives. This aspiration inspires and unites the approximately 127,100 employees of Johnson & Johnson across more than 250 operating companies in 60 countries. We embrace research and science, bringing innovative ideas, products and services to advance the health and well-being of people. For 130 years, the Johnson & Johnson Family of Companies has been committed to caring for people around the world.

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020

  • 4.2/5 in overall job satisfaction

  • 4.3/5 in supportive management

  • 72% say women are treated fairly and equally to men

  • 88% would recommend this company to other women

  • 85% say the CEO supports gender diversity

  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).

  • Global exercise reimbursement.

  • Two weeks off (one of them fully paid) for volunteer work.