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:
- 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.
- Communication & Technical Writing: Strong written and verbal communication skills with a customer-service orientation when collaborating across all organizational levels.
- Software Proficiency: 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. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contacts you.
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities.
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