companyNeuralink logo

Document Control Specialist

NeuralinkAustin, Texas, United States
On-site Full-time

Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.


Unlock Your Potential

Generate Job-Optimized Resume

One Click And Our AI Optimizes Your Resume to Match The Job Description.

Is Your Resume Optimized For This Role?

Find Out If You're Highlighting The Right Skills And Fix What's Missing

Experience Level

Experience

Qualifications

Required Qualifications:Exceptional attention to detail and organizational skills. Previous experience in document control within a regulated environment is preferred. Strong understanding of FDA regulations and GxP requirements. Proficient in document management software and tools. Excellent communication and interpersonal skills.

About the job

About Neuralink:

At Neuralink, we are pioneering cutting-edge technology to forge a direct link between the brain and external devices. Our innovative devices aim to restore mobility to those with paralysis, vision to the visually impaired, and to transform human interaction with digital environments.

Team Description:

Become a vital member of Neuralink's Quality Team, a collective of skilled professionals dedicated to establishing and maintaining exceptional quality and compliance frameworks. Our focus is to surpass regulatory standards and industry best practices, facilitating the rapid and safe advancement of Neuralink's groundbreaking technologies.

Job Description and Responsibilities:

Neuralink is in search of a meticulous Document Control Specialist who will be instrumental in overseeing document control activities across the organization. This pivotal role will involve organizing and managing essential documentation across various departments including preclinical, manufacturing, engineering, quality, and regulatory. You will play a key role in enhancing processes, archiving, and compliance tracking to ensure traceability, version control, and audit readiness in a highly regulated environment. Your responsibilities will also include:

  • Enhancing and maintaining document control systems in accordance with FDA regulations (e.g., 21 CFR Part 11, 21 CFR 58, 21 CFR 812) and GxP requirements.
  • Structuring GxP files (including study records, lab data, equipment logs, and audit documentation) into an accessible, traceable, and searchable system.
  • Overseeing archives for GxP studies and ensuring proper retention, deprecation, and re-indexing as necessary.
  • Assisting in the development, revision, and periodic review of Standard Operating Procedures (SOPs) and maintaining corresponding tables of contents.
  • Supporting the upkeep of study trackers, training assignments, master schedules, and glossaries.
  • Facilitating the management of deviations and investigations.
  • Handling document lifecycles, including versioning, deprecation of outdated documents, and approval workflows.
  • Assisting the Regulatory department by organizing regulatory filings, managing eTMF uploads, and preparing routine submission documents.

About Neuralink

Neuralink is at the forefront of neurotechnology, developing innovative solutions that merge the human brain with advanced computing technology. Our mission is to empower individuals with disabilities and enhance human capabilities through our groundbreaking devices.

Similar jobs

Tailoring 0 resumes

We'll move completed jobs to Ready to Apply automatically.