质量专员(QA)
广州燃石医学检验所有限公司
- 公司规模:1000-5000人
- 公司性质:民营公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-07-15
- 工作地点:广州-海珠区
- 招聘人数:若干人
- 工作经验:无工作经验
- 学历要求:招若干人
- 语言要求:不限
- 职位月薪:6-8千/月
- 职位类别:医疗器械生产/质量管理 药品生产/质量管理
职位描述
工作职责:
1 、按照相关法律法规行业质量规范,协助梳理并撰写实验室质量管理体系文件;
2 、 按照相关SOP要求,协助开展定期内部审查,总体监督实验室质量体系的运行和操作 ;
3 、日常CAPA跟进,确保有效的CAPA措施得以制定并执行 ;
4 、外部投诉或抱怨事故的跟进,确保有效的CAPA措施得以制定并执行;
5 、协助安排协调迎接来自客户或官方的外部质量审查;
6 、文件控制:文件发放、打印、回收、作废等;
7 、记录控制:记录收取、交接、归档、保存等;
8 、完成直属领导交办的其他相关工作任务。
任职要求:
1、英文书写和阅读能力良好
2、责任心强,踏实;
3、有风险意识,善于发现问题本质、并能提出切实有效的解决方案;
4、良好的口头及书面表达能力;
5、良好的人际沟通能力,沟通表达能力较强;
6、工作积极主动,细致认真。
学历要求:
药学、医学、生物等生命科学相关专业,本科及以上学历,熟悉PCR理论或实验技术的优先考虑
职能类别: 医疗器械生产/质量管理 药品生产/质量管理
公司介绍
关于燃石医学
燃石医学(纳斯达克代码:BNR)成立于2014年,公司使命为“用科学守护生命之光”,专注于为肿瘤精准医疗提供具有临床价值的二代基因测序(NGS)。公司业务及研发方向主要覆盖:1)基于NGS的肿瘤患病人群检测,6年间,燃石累计检测样本超过18.5万例,在中国市场份额领跑行业;2)基于NGS的癌症早检,目前已经进入临床验证阶段。
燃石医学于2018年7月率先获国家药品监督管理局(NMPA)颁发的中国肿瘤NGS检测试剂盒,在体外诊断领域具有里程碑式意义。实验室获得广东省临检中心颁发的 “高通量测序实验室”技术审核,以及得美国CLIA和CAP实验室质量体系资质认证。公司将继续致力于开发创新可靠的NGS检测产品,推动肿瘤精准医疗领域的发展。
About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to Guard Life via Science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, with the leading market share in China and over 185,000 tissue and liquid-based tests completed cumulatively, and ii) NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.
In July 2018, Burning Rock received the first approval for a tumor NGS kit by the National Medical Products Administration (NMPA), which is a significant milestone in the field of in vitro diagnosis in China. Burning Rock’s laboratory has obtained the technical certification of “High-throughput sequencing laboratory” issued by Guangdong Center for Clinical Laboratory, and the CLIA and CAP laboratory quality system certification. The company continues to be committed to the development of innovative and reliable NGS testing products and promoting the development of precision medicine in oncology.
燃石医学(纳斯达克代码:BNR)成立于2014年,公司使命为“用科学守护生命之光”,专注于为肿瘤精准医疗提供具有临床价值的二代基因测序(NGS)。公司业务及研发方向主要覆盖:1)基于NGS的肿瘤患病人群检测,6年间,燃石累计检测样本超过18.5万例,在中国市场份额领跑行业;2)基于NGS的癌症早检,目前已经进入临床验证阶段。
燃石医学于2018年7月率先获国家药品监督管理局(NMPA)颁发的中国肿瘤NGS检测试剂盒,在体外诊断领域具有里程碑式意义。实验室获得广东省临检中心颁发的 “高通量测序实验室”技术审核,以及得美国CLIA和CAP实验室质量体系资质认证。公司将继续致力于开发创新可靠的NGS检测产品,推动肿瘤精准医疗领域的发展。
About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to Guard Life via Science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, with the leading market share in China and over 185,000 tissue and liquid-based tests completed cumulatively, and ii) NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.
In July 2018, Burning Rock received the first approval for a tumor NGS kit by the National Medical Products Administration (NMPA), which is a significant milestone in the field of in vitro diagnosis in China. Burning Rock’s laboratory has obtained the technical certification of “High-throughput sequencing laboratory” issued by Guangdong Center for Clinical Laboratory, and the CLIA and CAP laboratory quality system certification. The company continues to be committed to the development of innovative and reliable NGS testing products and promoting the development of precision medicine in oncology.
联系方式
- Email:simin.huang@brbiotech.com
- 公司地址:广州国际生物岛星岛环北路5号(燃石医学)
- 电话:17710099363