The opportunity
This is a full-time, contract hybrid position in South San Francisco, CA. The Contract Design Control Scientist supports the Platform department by owning and improving design controlled documentation across the product development lifecycle.
What you'll do
Author and maintain design controlled documentation in compliance with FDA: QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and GDPR.
Translate laboratory processes, study plans, and analytical data into: traceable, compliant deliverables (e.g., development reports, verification/validation protocols, specifications).
Establish and maintain traceability across project documentation, linking: requirements to design outputs and verification evidence.
Review development reports, team resources, and software scripts to extract: and synthesize information for controlled documents.
Create onboarding and training documentation for R&D and CLIA team members,: including training plans and departmental practice descriptions.
Manage documentation filing, version control, and change-control workflows within quality management systems.
What they're looking for
- BS or higher in a scientific discipline (molecular biology, biochemistry,: genomics, or related field) or equivalent industry experience.
- + years of experience producing controlled documentation in the medical device, IVD, or life science industry.
- Demonstrated experience working in a regulated environment with knowledge of: FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and/or GDPR.
- Experience interpreting software implementations and structured data formats: (JSON, XML) for documentation purposes.
- Track record of working cross-functionally with Engineering, Product: Management, Data Science, Biostatistics, Science, and RA/QA teams.
