R&D Assay Documentation Specialist (HYBRID: Chicago, IL)
$50k - $55kAmbry Genetics
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.
Responsibilities
- 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
Requirements
- 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
Compensation: $50,000-$55,000
Vacancy posted 12 days ago
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