Microbiologist

About the role

Cochlear is the global market leader in implant hearing solutions. Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer from severe hearing loss. It's an incredible piece of engineering and the only product in the world that restores a sense through technology. Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear. 科利耳是全球领先的植入式听力解决方案专家。我们的使命是帮助人们聆听声音同时帮助他们被聆听。在全球选择科利耳听力植入系统的人是最多的。人工耳蜗是一种电子设备，通过手术将该设备植入耳朵附近的皮肤下，以帮助患有严重听力损失人群恢复听力。这是世界上唯一能够运用技术恢复感官的产品，是一项令人难以置信的工程。想象一下，你能够运用自己的经验去帮助世界各地的人们重获听力。我们可以提供这一独特的机会，加入科利耳，一家标志性的澳大利亚公司，在可植入听力解决方案方面引领世界。我们的使命是帮助更多的人获得听力。 Cochlear Medical Device (Chengdu) Co., Limited is a wholly-owned subsidiary of Cochlear Co., Ltd. in China. It was established in Tianfu New Area, Chengdu, Sichuan Province in September 2017. As Cochlear's only manufacturing site in China, it mainly produces cochlear implants and sound processors, providing professional assistance to the hearing impaired in China and other markets 澳科利耳医疗器械（成都）有限公司是科利耳有限公司在中国成立的全资子公司，于2017年9月在四川省成都市天府新区成立。做为Cochlear在中国唯一的制造中心，主要生产人工耳蜗植入设备和声音处理器，为中国及其他市场的听力损失人士提供专业帮助。 In order to help Cochlear bring products to market that help people with hearing loss, we are recruiting to support the new manufacturing site in Chengdu China. 为了将产品推向市场来帮助有听力损失的人群，我们正在为成都工厂招聘一名。 This role will be based in Chengdu, China. In this role you'll have the opportunity to make a significant contribution to Cochlear's successful history by applying your knowledge and experiences. 该岗位工作地点为中国成都。在该岗位上，您将有机会运用自己的知识和经验为科利耳的成功做出重大贡献。 Position Overview / Purpose 职位概述 T he role is responsible for the laboratory test activities implementation and ensuring the test activities comply with the Good Laboratory Practice (GLP) and relevant procedure. 主要职责是实验室测试 活动 和确保测试过程符合良好实验室规范及相关程序。 To ensure Manufacturing complies with latest regulatory and industry standards in the fields of microbiology, and where these standards are not met the appropriate action is taken immediately. 确保制造过程符合微生物的最新监管和行业标准，如果不符合这些标准，则立即采取适当的行动。 Accountability 主要职责 1: Production S upport 生产支持 Provide the contact for production on microbiological issues. 就微生物相关问题作为生产方面的联系人。 Provide solutions to support lean manufacturing practices to identified production problems related to the microbial control of production areas (including cleanrooms), other microbiology issues both short and long term. 提供解决方案，支持开展精益制造实践活动，以解决已确定的与生产区域（包括洁净室）的微生物控制、其它微生物相关问题。 Ensure NCR's, Concessions and Change Notes are processed in a timely manner. 确保 NCR 、让步和变更记录得到及时处理。 Ensure that Good Manufacturing Practice (GMP) is followed in the Production Support Group. 确保生产支持工作组遵循质量管理规范 (GMP) 开展工作。 Provide appropriate training to production personnel in correct procedures to maintain microbiological controls in all production areas (e.g. cleanroom). 为生产人员提供相应培训，使其掌握正确的规程，以保持在所有生产区域（如洁净室）内进行微生物控制。 Coordinate the timely dispatch of testing implementation of manufacturing p rocess . Send test samples to external test laboratories and receipt of test reports when required. 协调工作，保证及时 进行样品测试。如有需求，将 测试样品发往外部测试实验室，并在必要时接收测试报告。 Accountability 主要职责 2: L aboratory 实验室 Perform chemical & microbial test according to site monitoring plan for material/process water/environment/product. etc, such as sterility test, bioburden test, particulate test 根据工厂监测计划，对原料 / 工艺用水 / 环境 / 产品等进行理化及微生物检测。检测类型例如无菌测试 / 微生物限度测试 / 颗粒度测试等 Receive and decontaminate returned implant devices and/or sub-systems/components in the decontamination laboratory. Document information of returned device and decontamination process. 在去污实验室接收和去污返回的植入设备和 / 或子系统 / 组件。记录返回的设备 及去污染过程的信息。 Manage the reagent and consumables: prepare media and solution as required; Make sure the storage & handling of reagent & consumables comply with the requirement 管理试剂及耗材：根据需要准备培养基及试剂；确保试剂及耗材的储存符合相关要求 Inform production management immediately of any occurrence of a microbial test results being outside the acceptable limits and follow the control of the nonconforming procedure. 如果发生任何微生物测试结果超出可接受范围的情况，应立即通知生产管理 层，并遵循不合格项控制规程进行处理。 Analyse Laboratory abnormal d ata immediately as it becomes available and provide preventative and corrective actions and ensure adequate review process in place with stakeholders. Perform the CAPA as needed 在获得 实验室 异常 数据后，立即对其进行分析，并提供预防和纠正措施，确保与相关方共同建立合适的审核流程。 如若需要，完成纠偏及预防措施 Assist in the routine auditing of (a) contract microbiological testing laboratories and (b) internal compliance to CCD Site monitoring control pro cedures. 协助对 (a) 订有合约的微生物测试实验室，以及 (b) 针对 CCD 基地监测控制规 程的内部合规情况进行例行审核。 Ensure all microbial and chem

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