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