R&D Assay Documentation Specialist

. Support validation protocol, report, and technical document preparation, compilation, editing, maintenance, and filing .

Posted 9/25/2026full-timeChicago • Illinois • United StatesJuniorMid-Level💰 $50,000 - $55,000 per yearWebsite

Key responsibilities & impact

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
Review documentation 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
Continuously improve IVD and LDT development documentation and processes
Work closely with Technical and Development Scientists, technologists, Quality, and Regulatory professionals
Support the molecular R&D group in drafting documentation for regulatory submissions

What you’ll need

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
Experience in a lab setting in life sciences and a thorough understanding of molecular biology and associated techniques (highly desirable)
Ability to thrive in a fast paced environment (highly desirable)
Familiarity with a range of QMS systems and regulatory submissions (highly desirable)
Familiarity with ISO 13485 and FDA QSMR (highly desirable)

Comp & perks