杭州招聘

·       Design, implement and optimize operational and quality policies and procedures, ensuring compliance with all applicable regulations (e.g. GLP, GCLP, CLIA, etc.), guidance, and standards, while ensuring business processes are designed to maximize value for internal and external clients

设计，实施和优化运营和质量政策和程序，确保遵守所有适用法规（例如GLP，GCLP，CLIA等），指南和标准，同时确保业务流程设计可将内部和外部客户的价值***化。

·       Collect and monitor performance metrics, including identification of trends that require preventive action and the steps necessary to improve performance 

收集和监控绩效指标，包括确定是否需要提前采取预防措施及如何提高成效。

·       Monitor daily work operations and provide direction and guidance to staff to achieve unit or project goals. Interact with internal and external clients, by meeting regularly, responding to requests and explaining procedures

监控日常工作操作，为员工提供指导和方向，以实现单位或项目目标。通过定期会议，与内部和外部客户进行沟通，响应客户需求和解释项目流程。

·       Verify accuracy of analytical results and sample identification; inventories and submits data to archives. Provides support for quality investigations and contracted services.

验证分析结果和样品鉴定的准确性;检查库存并将数据存档。为质量调查和签约服务提供支持。

·       Serve as subject matter expert for process/vendor audits or activities in area of expertise, e.g. reviews lab investigations or root cause analysis.

负责程序，供应商审计或相关专业领域的工作，例如审查/监察实验室或根本原因分析。

·       Host client and regulatory inspections/audits, and participate in developing and tracking corrective actions.

主持客户和监管机构检查/审核，并参与制定和跟踪纠正措施。

·       Provide training for department and/or laboratory staff where required.

在必要时，为部门和/或实验室工作人员提供培训。

Requirements:

? 教育和经验

o学士学位或同等学历，以及相关的正式学术/职业资格

o拥有三年以上实验室或QA经验，具备相关专业知识技术和能力

? 知识，技能和能力

o具备全球行业***的工作实践经验，相关指导和法规的知识，包括了解GLP，GCLP，CLIA，ICH以及相应的区域性法规和指南

o具有项目或内部GLP / GCLP审核和供应商审核的工作经验

o优秀的口头和书面沟通技巧

o强大的问题解决能力，风险评估和影响分析能力

o了解根本原因分析工具和应用程序，持续采取纠正/预防措施，并参与流程改进

o能够在最低限度监督的环境中独立运作，并且需要特别注重细节

o能够按时完成任务并执行管理效力

Amador Bioscience strives to provide global-standard laboratory, clinical research, strategy consulting and regulatory filing services to biopharmaceutical companies. The laboratory services focus on PK/PD/ADA assay development and sample analysis. Amador clinical research unit specializes in innovative clinical development strategy and protocol design, and initiation and monitoring of clinical studies in China and US. In addition to R&D strategy and regulatory pathway, our consulting services perform global-standard data analysis and generate submission-ready study reports. We have successfully supported CTD filings in China and US.

With profound academic background and rich experience in R&D services in the biopharmaceutical industry, AmadorBio is a global clinical research team of pharmacologists, statisticians, bioanalytical scientists, translational & clinical scientists, medical scientists, clinical trial management experts, data management experts, quality assurance auditors, clinical trial managers and regulatory specialists. (40% of PhD, MD and PharmD, 35% of MS). AmadorBio provides professional services for more than 20 leading biopharmaceutical companies from early research and development, clinical development to regulatory submission in China and US.

AmadorBio operates in biotech hubs: San Francisco Bay Area, USA and Shanghai-Hangzhou-Suzhou region, China, providing comprehensive solutions complied with global standards and government drug inspection regulations in China and US.

The mission of Amador is to provide global-standard services facilitating the development of novel biotherapeutics.

    安渡生物致力于为生物医药公司提供全球标准的实验室、临床研究、策略咨询和监管申报服务。实验室服务专注于PK/PD/ADA方法学开发验证和样本分析。安渡生物的临床研究中心专注于为美国和中国的生物医药公司提供创新的临床研究开发策略、方案设计、启动和监查的专业服务。我们的咨询服务除研发策略和监管服务外，还可提供全球标准的数据分析并生成完备的申请报告。我们在中国和美国成功地支持了多家医药公司的CTD申请。

    安渡生物是一支具有资深学术背景、行业研发服务经验丰富的临床研究团队，拥有临床药理、数理统计、生物分析、转化科学、医学、临床运营、数据管理、质量保证审核、项目管理以及监管申报各方面专家，其中博士(PhD, MD, PharmD)占40%，硕士占35%。安渡团队致力于支持从临床前到临床各个阶段的药物开发计划。目前我们为20余家中美生物制药公司提供从早期研发，临床开发到监管申报等多个项目的专业服务。

    安渡生物在美国旧金山湾区和中国长三角地区设有办公室和实验室，提供涵盖中美及符合国际标准和政府药检规范的全方位解决方案。

    安渡生物的使命：提供全球标准的服务，促进新型生物药物开发。