Temp Senior Document Control Specialist – QA & Compliance

Personalis, Inc; Fremont (CA); Hybrid; USD 54,000 - 61,000; Full time

Job summary

Personalis, Inc. in Fremont, California, is seeking a Sr. Document Control Specialist (Temp) to join the Quality Assurance team.

The role requires strong document control expertise in regulated environments (ISO 13485, 21 CFR Part 820) and the ability to work with minimal supervision. Hybrid work schedule includes Mon & Tue, with responsibilities across DCO management, cross-functional collaboration, and QA support; 3+ years in regulated medical device or pharma, EDMS proficiency, and strong

Qualifications

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

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 elevate 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.

Skills

Attention to detail

Independence

Communication

Software proficiency

Education

Bachelor's degree or equivalent

Tools

EDMS

ComplianceQuest

Job description

Personalis, Inc. in Fremont, California, is seeking a Sr. Document Control Specialist (Temp) to join the Quality Assurance team.

The role requires strong document control expertise in regulated environments (ISO 13485, 21 CFR Part 820) and the ability to work with minimal supervision. Hybrid work schedule includes Mon & Tue, with responsibilities across DCO management, cross-functional collaboration, and QA support; 3+ years in regulated medical device or pharma, EDMS proficiency, and strong