Regulatory QA Specialist — GLP/GMP & FDA Audits

Future Ventures; Austin (TX); On-site; USD 35,817 - 61,992; Full time

Benefits offered by this job

Medical Insurance

Dental & Vision

Paid Holidays

Commuter Benefits

Equity (RSUs)

401(k) Plan

Parental Leave

Flexible Time Off

Job summary

Neuralink in Texas is seeking a Quality Assurance Specialist to ensure adherence to FDA, ISO, GLP, and related standards across our regulated processes. The role collaborates with cross-functional teams to drive compliant, reliable operations in our labs, clinics, and production environments.

The position focuses on audits, documentation, training, and continuous quality improvements, with responsibilities ranging from inspecting GLP activities to supporting FDA inspections and maintaining

Qualifications

• Bachelor of Science degree, preferably in a science, engineering, or quality-related discipline.
• Exposure to a regulated environment (e.g., FDA-regulated industry, GxP, ISO, or quality system work)
• Working knowledge of FDA regulatory requirements and standards
• Excellent communication and collaboration abilities
• Basic computer skills and proficiency in Google Docs, Google Drive, and Gmail
• Ability to travel to/from work in multistate locations

Responsibilities

• Conduct audits of GLP activities and assist with GMP, GCP, and engineering audits to ensure FDA compliance.
• Review evidence and issue findings for compliance concerns or deviations
• Verify no deviations from approved protocols without proper authorization/documentation
• Communicate QA inspection findings to management via signed reports
• Assist with deviation/audit findings tracking and closure of actions
• Maintain master schedule of GLP-regulated studies and approved protocols

Skills

Communication

Collaboration

Regulatory awareness

Auditing

Education

Bachelor of Science

Tools

Google Docs

Google Drive

Gmail

Job description

Neuralink in Texas is seeking a Quality Assurance Specialist to ensure adherence to FDA, ISO, GLP, and related standards across our regulated processes. The role collaborates with cross-functional teams to drive compliant, reliable operations in our labs, clinics, and production environments.

The position focuses on audits, documentation, training, and continuous quality improvements, with responsibilities ranging from inspecting GLP activities to supporting FDA inspections and maintaining