Personalis, Inc

Personalis, Inc

Sr. Document Control Specialist (Temp - 3 Month)

Fremont, CA · Senior · Contract

Sponsorship not specified$39k-$44kDetected 49 days ago
AlgorithmsAccessibilityExcelFDA RegulatoryMedical DevicesCommunicationCollaborationWritingMicrosoft Office

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odds of building a lasting career here

37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70

Thin sponsorship signal and lottery-bound (~15% per draw). A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.

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About the role

  • Personalis is based in Fremont, California.
  • 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.
  • Attention to Detail: High precision in proofreading, formatting, and verifying document compliance against established templates and requirements.
  • Independence & Prioritization: Proven ability to work independently, prioritize competing tasks, and manage workload in a fast-paced environment.
  • 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.

Requirements

  • Bachelor's degree or equivalent experience in a document control capacity.
  • Regulatory Knowledge: Sound working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
  • Software Proficiency: Advanced skills in Microsoft Office (Word, Excel, PowerPoint), Adobe Acrobat, and Google Workspace.

Nice to have

  • 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.
  • Systems: Hands-on experience with Electronic Document Management Systems (EDMS).

Skills

  • Independence & Prioritization:
  • Communication & Technical Writing:
  • Strong written and verbal communication skills with a customer-service orientation when collaborating across all organizational levels.
  • Advanced skills in Microsoft Office (Word, Excel, PowerPoint), Adobe Acrobat, and Google Workspace.
  • The hiring range for this position is $39.00 to $44.00 per hour, which may factor in various geographic regions.
  • Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals.
  • Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities.
  • Attention to Detail:
  • Software Proficiency:
  • #LI-JT1 #LI-Onsite

Compensation

  • $39k-$44k

Benefits

  • Education & Experience Requirements:
  • Education: Bachelor's degree or equivalent experience in a document control capacity.

Company info

  • At Personalis, we are transforming the active management of cancer through breakthrough personalized testing.
  • As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations.
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