R&D Assay Documentation Specialist

Tempus AI•Chicago, IL

About The Position

Tempus is seeking a key contributor for IVD projects to generate design documents, reports, SOPs, and other documentation for the development of diagnostic assays. This role involves applying experience in quality and regulatory documentation to support the molecular R&D group in drafting documentation for regulatory submissions. You will collaborate closely with Technical and Development Scientists, technologists, and Quality and Regulatory professionals.

Requirements

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 with cross functional teams
Team driven

Nice To Haves

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

Responsibilities

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