Sr. Document Control Specialist (6 Month -Temp)

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 (Temp) will be an integral member of the Quality team. The primary responsibility is to maintain the daily activities within the Document Control function. The ideal candidate has knowledge and experience working in regulated environments (i.e. ISO 13485, 21 CFR Part 820) and sufficient knowledge and experience working in Quality to operate with minimal supervision. This position reports to the Associate Director, Document Control

Responsibilities:

• Work on Document Control activities either independently or with minimal supervision.

• Ensure that documentation and data related to the Quality System requirements are meticulously controlled to maintain their integrity and accessibility.

• Review, revise and control various documents to comply with internal and external requirements.

• Edit and proofread documents for accuracy, clarity and consistency.

• Reviews all documents for change to ensure the use of correct templates and key quality requirements and resolves issues with the initiator of the change.

• Coordinate the approval process for documents, ensuring timely reviews and approvals.

• Work closely with various departments to gather necessary information and feedback for document creation and revision to ensure documents and change orders meet all necessary requirements.

• Ensure document control activities such as document management, version control and distribution management are executed in a timely fashion and in accordance with regulatory requirements.

• Follow through - completes the tasks and any needed follow up activities, including escalation of system errors and past due documents.

• Support the maintenance of periodic document review

• Work on multiple projects simultaneously.

• Duties also may include word processing, filing quality records, and other project related activities as needed.

• Additional duties as assigned.

Education and Experience:

• Bachelor's degree or equivalent experience in a document control role

• 3+ years' experience in document control - developing/enhancing, implementing, and maintaining documentation systems which comply with regulatory requirements.

• Experience working in a regulated Medical Device or Pharma environment

• Ability to work independently

• Must be detail oriented, review documents with specific requirements in mind and ensure the posting process is completed.

• Ability to prioritize and organize workload to meet business needs and turnaround time requirements.

• Strong abilities in Microsoft Office applications.

• Excellent technical writing and verbal communication skills.

• Expert in Microsoft Word, Excel, and Power Point, Adobe Acrobat

• Familiar with Google Suite

• Knowledge of document control management systems such as Compliance Quest is a big plus.

• Customer orientation - works in a supporting role and communicates with cross functional teams and partners at all levels in the organization.

The hiring range for this position is $36/hr to $42/hr, 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.

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.)

#LI-KK1 #LI-Hybrid