Sr. Document Control Specialist

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.

Summary:

The Sr. Document Control Specialist will be an integral member of the Quality Assurance & Regulatory Compliance team. The primary responsibility is to lead the Document Control components of the Personalis Quality Management System (QMS) ensuring adherence to established internal procedures and in compliance with applicable regulatory requirements, with a particular focus on ISO 13485:2016 and 21 CFR 820 alignment and compliance.

This role requires working cross functionally, in an independant and highly organized manner   the creation, review, revision, approval, distribution, storage and archiving of documents. The Sr. Document Control Specialist is extremely detail oriented and has experience working in regulated environments (i.e. ISO 13485:2016 and 21 CFR Part 820) and possesses sufficient knowledge of Document Control, including editing and formatting documents.  Additionally, experience using an electronic Quality system (eQMS) is required, with the ability to operate with minimal supervision. This position reports to Associate Director, Document Control and Training

Responsibilities:

• Lead  Document Control activities independently,  with minimal supervision.
• Ensure documentation and data related to the requirements of the Quality System are controlled in a manner, which ensures integrity and accessibility.
• Ensure document control activities such as document management, version control, distribution and reporting management are executed in a timely fashion and in accordance with regulatory requirements  (ISO 13485:2016 and 21 CFR Part 820).
• Update and maintain document control procedures and record keeping database.
• Review all documents for change to ensure the use of correct templates and key quality requirements and resolve issues with the initiator of the change.
• Ensure that the current revision of a controlled document is clearly defined in order to preclude the use of non-applicable documents.
• Maintenance of periodic document review.
• Mentor and train team members in Document Control processes.
• Work on multiple projects simultaneously.
• Duties also may include word processing, filling quality records, and other project related activities as needed.
• Create and present Document Control metrics and trends as needed.
• Support audits for licensure and accreditation documents submission.
• Assist in the management of onsite and offsite records.
• Support in the implementation of eQMS.
• Support Training manager on training requirements as needed.
• Participate in group meetings and present results. 
• Supportand ensure compliance with all department and company policies and procedures.
• Communicates effectively across teams to explain methodology, process, and results from analysis.

Qualifications:

• Bachelor’s in life or computer science preferred.
• Minimum of 5 years’ experience in Document Control, preferably within a regulated environment (e.g., medical device, biotechnology, pharmaceuticals).
• Experience with Quality Management System (QMS) and electronic Quality Management Systems (eQMS), such as Compliance Quest, Omnify or Agile.
• Strong abilities in Microsoft Office applications: Word, Excel and PowerPoint
• Excellent technical writing and verbal communication skills.
• Experience with Google Suite
• Extremely strong attention to detail and organizational skills.
• Ability to prioritize and organize workload to meet business needs and turnaround time requirements.
• Customer orientation – works in a supporting role and communicates with cross functional teams and partners at all levels in the organization.
• Follow through - completes the tasks and any needed follow up activities, including escalation of system errors and past due documents.
• Problem-solving skills with the ability to analyze issues and develop effective solutions.
• Ability to work independently with minimal supervision as well as collaboratively within a team.

The hiring range for this position is $72,000 to $92,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

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. Personalis offers a competitive compensation package and benefits including medical, dental, vision, 401(k) match, ESPP, tuition reimbursement, sick/vacation time, commuter benefits/ EV charging stations, onsite gym, and wellness benefits. (For US only, benefits in other countries may vary.) 

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