Senior Document Control Specialist - Hybrid QA & Compliance

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

Benefits offered by this job

Hybrid schedule

Job summary

Personalis, Inc. in Fremont, CA is seeking a Sr. Document Control Specialist (Temp) to join the Quality Assurance team. You will manage DCOs, maintain controlled documents, and ensure compliance with ISO 13485 and 21 CFR Part 820, collaborating across departments in a fast-paced environment.

The role requires a Bachelor’s degree and 3+ years in regulated document control, with EDMS experience and CQ exposure. Hybrid work arrangement expected, reporting to the Director of Quality Assurance.

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). Experience with 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 EDMS to ensure clarity, consistency, and compliance.
• Cross-functional collaboration with change initiators and reviewers to resolve DCO discrepancies and expedite approvals.
• Quality Records & System Integrity: maintain accessibility of Quality System documentation, master signature logs, data, and records inventory.
• Periodic Reviews & Tracking: facilitate periodic document reviews and follow up on past-due items.
• General QA Support: manage multiple document projects and provide QA support as needed.

Skills

Attention to Detail

Independence

Technical Writing

Communication Skills

Education

Bachelor’s degree

Tools

EDMS

ComplianceQuest

Job description

Personalis, Inc. in Fremont, CA is seeking a Sr. Document Control Specialist (Temp) to join the Quality Assurance team. You will manage DCOs, maintain controlled documents, and ensure compliance with ISO 13485 and 21 CFR Part 820, collaborating across departments in a fast-paced environment.

The role requires a Bachelor’s degree and 3+ years in regulated document control, with EDMS experience and CQ exposure. Hybrid work arrangement expected, reporting to the Director of Quality Assurance.