QA（体系管理）
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：2020-12-25
- 工作地点：广州-海珠区
- 招聘人数：1人
- 工作经验：1年经验
- 学历要求：本科
- 职位月薪：4.5-6千/月
- 职位类别：药品生产/质量管理 医疗器械生产/质量管理
职位描述
工作职责：
1、建立健全各项QA相关文件，并实施；
2、负责对生产全过程进行监督，将生产过程中的差错降到最低；
3、参与供应商审计工作；
4、负责标签、说明书印制前的审核并建立相应的标签说明书档案；
5、完成上级领导安排的各项工作。
任职要求：
1、全日制本科以上学历，分子生物学相关专业
2、理解熟悉医疗器械或者IVD相关法律法规；
3、具备IVD QA质量管理经验，具有NGS产品经验优先；
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