研发检测文档专员
R&D Assay Documentation Specialist
对精准医疗和推动医疗行业发展充满热情吗？
近年来底层技术的进展终于使人工智能在临床护理中产生实质性影响成为可能。Tempus 的专有平台连接整个现实世界证据生态系统，为医生提供实时、可操作的见解，提供关于正确患者在正确时间接受正确治疗的关键信息。
我们正在寻找一位关键成员，参与 IVD 项目的设计文档、报告、SOP 和其他文件的编写，以支持诊断检测的开发。该职位需要应用质量与法规文件方面的经验，以支持分子研发团队起草法规提交文件。您将与技术与开发科学家、技术人员以及质量和法规专业人员密切合作。
您将负责：
- 支持验证协议、报告和技术文档的准备、汇编、编辑、维护和归档
- 起草和编辑符合质量体系的文件，如 SOP、批次记录和操作指南，用于实验室相关流程
- 跟踪 IVD 临床验证过程中产生的批次记录和检查清单，并确保合规性
- 维护适当的归档系统
- 对文件进行一致性与合规性审查
- 协助监督新文件的实施和版本控制
- 作为文件检索的联系人
- 协助准备内部和外部审计
- 管理多种信息来源用于文件编制
- 帮助持续改进 IVD 和 LDT 开发文件和流程
资格要求：
- 本科学位，加上医疗设备行业 2 年以上的文件编制经验
- 有条理且注重细节
- 出色的书面和口头表达能力
- 能够与跨职能团队良好协作
- 以团队为导向
非常希望您具备：
- 生命科学实验室环境中的经验，以及对分子生物学和相关技术的深入理解
- 能在快节奏环境中茁壮成长
- 熟悉多种 QMS 系统和法规提交
- 熟悉 ISO 13485 和 FDA QSMR
CHI：$50,000-$65,000
预期薪资范围可能因其他地点而异。实际薪资可能根据资历和经验有所不同。Tempus 提供全面的福利，可能包括激励性薪酬。
查看英文原文
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We are looking for a key contributor for IVD projects in the generation of design documents, reports, SOPs, and other documentation towards the development of diagnostic assays. The position involves applying experience in quality and regulatory documentation to support the molecular R&D group in drafting documentation for regulatory submissions. You will work closely with Technical and Development Scientists, technologists, as well as Quality and Regulatory professionals.
What you’ll do:
- Support validation protocol, report, and technical document preparation, compilation, editing, maintenance, and filing
- Draft and edit quality system compliant documentation such as SOPs, batch records, and work instructions for lab-related processes
- Track batch records and checklists produced during IVD clinical validations and ensure compliance
- Maintain appropriate filing systems
- Documentation review for consistency and compliance
- Help oversee implementation of new documentation and version control
- Serve as a point of contact for documentation retrieval
- Aid in preparation for internal and external audits
- Manage multiple sources of information for documentation purposes
- Help to continuously improve IVD and LDT development documentation and processes
Qualifications:
- Bachelor’s degree plus 2+ years of documentation experience in the medical device industry
- Organized and detail oriented
- Excellent written and verbal skills
- Ability to work well will cross functional teams
- Team driven
Highly desirable:
- Experience in a lab setting in life sciences and a thorough understanding of molecular biology and associated techniques
- Ability to thrive in a fast paced environment
- Familiarity with a range of QMS systems and regulatory submissions
- Familiarity with ISO 13485 and FDA QSMR
CHI: $50,000-$65,000
The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Originally posted on Himalayas