Document Control Specialist

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.

Hybrid: Mon & Tues

Summary:

The Sr. Document Control Specialist (Temp) will serve as a key member of the Quality Assurance team, maintaining daily document control operations across the organization. Operating with minimal supervision, the ideal candidate brings strong expertise in document control within regulated environments (e.g., ISO 13485, 21 CFR Part 820). This role reports directly to the Director, Quality Assurance.

Responsibilities:

• Document Change Order (DCO) Management: Triage, review, re-format, proofread, and process DCOs through the electronic document management system (EDMS) to ensure clarity, consistency, and compliance with internal and external quality standards.
• Cross-Functional Collaboration: Partner with change initiators and reviewers across departments to resolve DCO discrepancies and expedite approval workflows to meet turnaround times.
• Quality Records & System Integrity: Meticulously control, file, and maintain accessibility of Quality System documentation, master signature logs, data, and records inventory.
• Periodic Reviews & Tracking: Facilitate periodic document reviews, follow up on past-due items, and escalate system issues or bottlenecks as needed.
• General QA Support: Manage multiple document projects simultaneously and perform additional document control and QA support duties as assigned.

Education & Experience Requirements:

• Education: Bachelor’s degree or equivalent experience in a document control capacity.
• Experience: 3+ years of experience in document control within a regulated medical device, IVD, or pharmaceutical environment.
• Systems: Hands-on experience with Electronic Document Management Systems (EDMS). Experience with ComplianceQuest (CQ) is a plus.
• Regulatory Knowledge: Sound working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.

Skills & Competencies: