Company Description:
We are creating the future of brain-computer interfaces: building devices now that have the potential to help people with paralysis regain mobility and independence and invent new technologies that could expand our abilities, our community, and our world.
Team info:
The new hire is going to be a part of the Quality Assurance Team assisting in GLP compliance related activities.
Job Responsibilities:
- Become intimately familiar with GLPs, QA standard operating procedures (SOPs), FDA audit checklists, and the medical device regulatory process from research and development to first-in-human.
- Interact with technical specialists to assist with writing, editing, and performing with mock GLP audits to tune technical and equipment SOPs such that they comply with good laboratory practices.
- Create GLP and regulatory training materials, training presentations, and training records.
- Assist with setting up and maintaining document control for controlled documents, which includes: obtaining management approval signatures, photocopying, creating SOP and work station binders, ensuring the proper procedures for controlled documents are followed, etc.
- Performing procedures, facility, and equipment audits for GLP compliance.
- Assist with creating GLP and regulatory infrastructure (systems), which includes: surgical material lot tracking, reagent and solution tracking, sample / specimen tracking, document tracking and retention, etc.
- Assist with and/or fill in for various scribe and documentation roles over the course of the GLP study as needed to ensure GLP and regulatory compliance.
- Perform literature searches, summarize pertinent information, and apply information to meet Neuralink needs and goals.
Key qualifications :
- Undergraduate degree in a scientific discipline (e.g. life sciences, chemistry, biology, biotechnology, materials science), OR currently pursuing a graduate degree in a STEM field or in Regulatory Affairs.
- Must have strong written and oral communication skills, and enjoy independent learning, doing research, and presenting on a wide variety of topics.
- A strong understanding of the scientific method and engineering first principles.
- Enjoys working in a collaborative environment with a mission first, go-getter attitude
Preferred qualifications :
- Experience of 0-2 years in FDA regulated industry (Medical Devices or Biotechnology)
- Experience of 0-1 years in Quality Assurance or Quality Control
What we offer:
- 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; parental leave.
- Flexible time off + paid holidays.
- Equity + 401(k) plan.
- Commuter Benefits.
- Meals provided.
Multiple studies have found that a higher percentage of women and BIPOC candidates won't apply if they don't meet every listed qualification. Neuralink values candidates of all backgrounds. If you find yourself excited by our mission but you don't check every box in the description, we encourage you to apply anyway!
Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.