GLP Quality Assurance Specialist at Neuralink

Austin, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

12 May, 26

Salary

119000.0

Posted On

11 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, GLP, ISO Standards, Regulatory Compliance, Auditing, Documentation, Communication, Organization, Problem Solving, Training, Inspection, Data Verification, SOPs, Vendor Management, Scientific Method, Microbiology, Chemistry

Industry

Biotechnology Research

Description

About Neuralink: We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world. Team Description: Join the Quality Assurance Team, where our mission is to ensure compliance with relevant regulatory standards and ensure functional, consistent, and reliable operation of our regulated processes. We are a group of industry-experienced professionals who utilize creative problem-solving to identify gaps and help establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations. We seek a dynamic individual who thrives on continuous improvement and is passionate about implementing systems that drive compliance and optimize performance. Job Description and Responsibilities: The Quality Assurance (QA) Specialist will work with Neuralink's teams to ensure that the appropriate governing body regulations are followed. This includes, but is not limited to, adherence to ISO standards and the GLPs. Responsibilities will include: Maintaining copies of all approved protocols Maintaining a master schedule of all GLP-regulated studies Performing pre-qualification inspections of the testing facilities as needed Providing general periodic status reports to management and the study director pertaining to facility, quality control, and preclinical study compliance Inspecting and auditing at studies at critical phases and communicating findings to appropriate management Determining that no deviations from approved protocols or standard operating procedures were made without proper authorization and/or documentation Reviewing study protocols to ensure compliance before study initiation Verifying that final study reports accurately reflect the raw data, protocol, methods, and SOPs used in conducting the GLP study and preparing a Quality Assurance Statement to be included in the report Writing and reviewing Quality Assurance SOPs Reviewing equipment, software, and other computer-system validations and qualifications when applicable Inspecting critical vendors Ensuring personnel training records are maintained by staff Conduct GLP training for staff as needed Serving as a point of contact and assisting with FDA inspections Required Qualifications: Bachelor of Science degree, preferably in a science, engineering, or quality-related discipline Minimum of 1 year of experience in a medical device or life sciences organization Minimum of 1 year of experience within a regulatory environment Minimum of 1 year of experience with FDA regulations and requirements Basic computer skills and proficiency in Google Docs, Google Drive, and Gmail Ability to travel to/from work in multistate locations Preferred Qualifications: Experience auditing GLP processes Experience with auditing Strong understanding of the scientific method and engineering first principles Understanding within the fields of microbiology and chemistry Excellent organization and communication skills Keen eye for detail Work Environment: Office, lab, operating room, and animal care facilities Expected Compensation: The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees. Base Salary Range: $71,000—$119,000 USD What We Offer: Full-time employees are eligible for the following benefits listed below. An opportunity to change the world and work with some of the smartest and most talented experts from different fields Growth potential; we rapidly advance team members who have an outsized impact Excellent medical, dental, and vision insurance through a PPO plan Paid holidays Commuter benefits Meals provided Equity (RSUs) *Temporary Employees & Interns excluded 401(k) plan *Interns initially excluded until they work 1,000 hours Parental leave *Temporary Employees & Interns excluded Flexible time off *Temporary Employees & Interns excluded

Responsibilities

The Quality Assurance Specialist will ensure compliance with governing body regulations, including ISO standards and GLPs. Responsibilities include maintaining protocols, conducting inspections, and reviewing study compliance.