Contract Design Control Scientist

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. This role bridges R&D science and regulatory compliance; translating labor...

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.
Identify opportunities to improve documentation processes, templates, and deliverable quality.
Perform other duties as assigned.

 

BS or higher in a scientific discipline (molecular biology, biochemistry, genomics, or related field) or equivalent industry experience.
5+ 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.

 
Strong scientific literacy with the ability to rapidly learn and document complex molecular biology and bioinformatics workflows.
Excellent written communication; clear, concise, and precise in producing regulated documentation.
Strong attention to detail, particularly around traceability and regulatory language.
Proficiency with quality management systems and document-control platforms (e.g., MasterControl) and collaboration tools (e.g., Confluence).
Working knowledge of the product-development lifecycle and change-control management processes.
Self-directed with the ability to manage multiple documentation deliverables independently.
Preferred domain knowledge: LIMS, LIS, LES, and/or ELN; genomics data-analysis pipelines; laboratory instrumentation and software-compliance requirements.
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
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