--- title: 'Sr. Document Control Specialist (Temp - 3 Month) at Personalis, Inc' canonical: 'https://feeny.ai/job/sr-document-control-specialist-temp-3-month-personalis-inc-fremont-wwh23wz4hmyy' type: 'job' last_seen: '2026-09-17' --- # Sr. Document Control Specialist (Temp - 3 Month) at Personalis, Inc - **Company:** Personalis, Inc - **Location:** Fremont, CA - **Posted:** 2026-09-03 - **Last confirmed live:** 2026-09-17 - **Apply:** https://job-boards.greenhouse.io/personalisinc/jobs/7984730003 ## Job description 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. #LI-JT1 #LI-Onsite ## About Personalis, Inc ## Company Overview - **One-liner**: Personalis is a precision oncology company that transforms the active management of cancer through advanced, personalized genomic testing and ultra-sensitive circulating tumor DNA (ctDNA) detection. - **Entity Type**: Public (NASDAQ: PSNL) - **Headquarters**: Fremont, California, United States - **Founded**: 2011 - **Founders**: Not publicly listed as a single founder; the company was founded by a team of genomics experts from Stanford University and the broader life sciences community. ## Core Business - **Primary industry/industries**: Precision Oncology, Biotechnology, Genomic Testing, Molecular Diagnostics - **Target customers**: B2B — primarily oncologists, hospitals, cancer centers, and biopharmaceutical companies (for drug development and clinical trials) - **Mission or purpose statement**: "Revealing the unique genetic signatures of solid tumors" to enable earlier cancer detection, more effective treatment selection, and better patient outcomes. ## Products & Services - **NeXT Personal Dx**: An ultra-sensitive, personalized blood test that detects circulating tumor DNA (ctDNA) to monitor for cancer recurrence. It can detect as little as 1 tumor DNA fragment in 1 million normal cells, often identifying recurrence months to years before standard imaging. Approved for Medicare reimbursement for breast cancer (Q4 2025) and non-small cell lung cancer (Q1 2026) surveillance. - **NeXT Dx**: A comprehensive genomic profiling test for solid tumors, used to guide therapy selection. Approved for Medicare reimbursement (Q1 2024). - **NeXT Personal (Pharma Services)**: A highly sensitive ctDNA assay used by biopharma partners for clinical trials, enabling early detection of molecular residual disease (MRD) and monitoring of treatment response. - **Advanced Tumor Profiling**: Ultra-comprehensive genomic profiling services for biopharma partners to optimize patient selection and biomarker strategy in drug development. ## Market Standing - **Valuation/Market Cap**: ~$872.9 million (as of mid-2026) - **Key Metric**: Annual Revenue — $69.6 million (2025); 2026 guidance of $78–80 million total company revenue, with NeXT Personal strategic revenue estimated at $30–32 million. - **Notable Investors/Partners**: Merck (post-IPO equity investment of $50M in Dec 2024), Tempus (post-IPO equity investment of $36.1M in Aug 2024), Lightspeed Venture Partners (led Series C), Myriad Genetics (non-exclusive IP access agreement, 2024). - **Growth Signals**: 26% revenue growth rate at the midpoint of 2026 guidance; over 25,000 tests delivered to date; Medicare reimbursement approvals for NeXT Personal Dx in breast and lung cancer; strong cash position of ~$233 million with no debt; 16% year-over-year headcount growth. ## Competitive Advantages - **Ultra-Sensitive Technology**: NeXT Personal Dx can detect 1 tumor DNA fragment in 1 million normal cells, offering a "1-in-a-million" sensitivity that often detects recurrence 5–15 months earlier than standard imaging. - **Personalized Approach**: The test identifies up to 1,800 unique DNA markers from each patient's tumor, creating a truly personalized liquid biopsy. - **Strong IP Moat**: Over 70 patents worldwide and 38 U.S. patents, providing robust legal protection for their technology. - **Proven Reimbursement Path**: Successfully navigated Medicare coverage for both NeXT Dx and NeXT Personal Dx, a critical barrier to entry in the U.S. diagnostics market. - **Strategic Partnerships**: Deep collaborations with biopharma leaders (Merck, Tempus) and a strong network of academic and clinical partners. ## Strategic Focus - **Accelerating Clinical Test Volume**: Driving adoption of NeXT Personal Dx through Medicare reimbursement and expanding clinical evidence across breast, lung, colorectal, and other cancers. - **Expanding Evidence Base**: Conducting studies in breast, colorectal, and lung cancer, as well as immunotherapy monitoring, to broaden clinical utility and payer coverage. - **Biopharma Partnerships**: Growing the pharma services business by enabling drug developers with ultra-sensitive MRD and therapy selection assays. - **Operational Efficiency**: Scaling clinical test volume to improve gross margins and drive toward profitability, supported by a strong cash position. ## Why Work Here - **Mission-Driven Work**: Employees directly contribute to transforming cancer care by enabling earlier detection and more personalized treatment for patients. - **Growth Trajectory**: The company is in a high-growth phase (26% revenue growth guidance for 2026), with expanding Medicare coverage and a strong pipeline of clinical studies. - **Culture & Environment**: Rated 3.6/5.0 on employer review sites, with particular strengths in compensation (3.6) and culture (3.6). The company values scientific rigor and innovation. - **Work Policy**: Based in Fremont, CA, with a second office in Menlo Park. The company operates in a hybrid/office environment typical of a biotech R&D and lab operations setting. - **Notable Perks**: Opportunity to work at the cutting edge of genomics and precision oncology; strong IP and scientific culture; involvement in high-impact clinical studies and publications. - **Engineering & Science Culture**: Heavy emphasis on bioinformatics, assay development, and clinical science. The workforce is heavily weighted toward medical, technical, and research roles. ## Sources 1. [Personalis.com](https://www.personalis.com/) 2. [Personalis Careers Page](https://job-boards.greenhouse.io/personalisinc) 3. [Personalis Company Page](http://www.personalis.com/company/) 4. [LinkedIn - Personalis](https://www.linkedin.com/company/personalis-inc) 5. 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