R&D Assay Documentation Specialist (HYBIRD: Chicago, IL)
Ambry Genetics · Chicago
ResearchFull-time$50k–$55kCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Ambry Genetics seeks an R&D Assay Documentation Specialist to support in vitro diagnostic development by creating and maintaining regulatory documentation, SOPs, and validation reports. The hybrid role in Chicago involves collaborating with scientists and quality professionals to ensure compliance and prepare submissions.
What they're looking for
- Bachelor's degree plus 2+ years medical device documentation experience
- Organized, detail-oriented with excellent written and verbal communication
- Ability to work effectively across cross-functional teams
- Lab experience in life sciences with molecular biology knowledge preferred
- Familiarity with ISO 13485, FDA QSMR, and QMS systems preferred
What you'll be doing
- Support validation protocol and technical document preparation, compilation, and editing
- Draft quality system compliant SOPs, batch records, and work instructions for lab processes
- Track batch records and checklists during IVD validations to ensure compliance
- Conduct documentation reviews for consistency and regulatory compliance
- Aid in audit preparation and manage documentation retrieval as needed
Privacy & handoff
This role links to Ambry Genetics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.