Position SummaryThis 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 laboratory processes, study data, and software workflows into traceable, audit-ready deliverables. The ideal candidate combines a strong scientific foundation with the ability to navigate regulated environments, engage cross-functional stakeholders, and communicate complex technical concepts to audiences ranging from R&D scientists to clinical professionals.
Primary Responsibilities- 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.
Qualifications- 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.
Knowledge, Skills, and Abilities- 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.
