R&D Documentation Specialist at Tempus
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 Scientists, Software Developers, as well as Quality and Regulatory professionals.
What you’ll do:
- Study report and technical document preparation, compilation, editing, and filing
Draft and edit quality system compliant documentation such as SOPs, batch records, work instructions for lab-related processes
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
Management of multiple sources of information for documentation purposes
- Bachelor’s degree plus 2 years of documentation experience in the medical device industry
Organized and detail oriented
Excellent written and verbal skills
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