R&D Assay Documentation Specialist (HYBRID: Chicago, IL)

Ambry Genetics · Chicago

RoleLantern checked

ResearchFull-time$50k–$55kCompany career page

The apply link worked recently (not employer-confirmed).

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.

What RoleLantern checked

This role is listed from an approved source. RoleLantern checks that the application link is live and how recently the role appeared — the employer has not confirmed it directly on RoleLantern.

RoleLantern checked active

RoleLantern checkedPay range listed

Date posted6 days ago

Last source checkToday

Salary listedListed

Location clearClear

Something look off? Let us know and we may ask the employer to verify it.

See how you match this role

Upload your CV to see which of this role's requirements your background supports, where there may be gaps, and what needs clarification. Private by default — we never sell your CV.

See my match