Senior GxP Documentation & QA Systems Lead

Neurona Therapeutics; South San Francisco (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Neurona Therapeutics in South San Francisco, CA is seeking a Sr. Documentation Control Specialist to support the Quality Management System, document control activities, and QA operations. The role ensures accurate, inspection-ready documentation in alignment with GxP requirements.

You will partner with GMP and clinical quality teams, support CAPAs, deviations, change control, audits, training, and quality metrics. This is a hands-on, on-site role in a dynamic biotech startup.

Qualifications

• Minimum 5+ years of experience in Quality Assurance, Quality Systems, or Document Control.
• Experience in GxP environments and GCP/GMP familiarity.
• Proficient with eQMS and document control processes.
• Strong Excel skills for tracking and reporting.
• Excellent written and verbal communication.

Responsibilities

• Lead day-to-day document control activities within the QMS.
• Organize and archive GxP documentation for inspection readiness.
• Collaborate with GMP and GCP quality teams for system activities.
• Support training curriculums, deviation/CAPA, change control, and audits.
• Assist with internal and external audits and tracking.
• Develop quality metrics dashboards and trending tools.
• Ensure data integrity and ALCOA++ compliance.

Skills

GxP Document Control

QMS/eQMS

Audit Support

CAPA Tracking

Excel Proficiency

Documentation Writing

Cross-functional Collaboration

Education

Bachelor's degree in scientific discipline

Tools

Excel

Job description

Neurona Therapeutics in South San Francisco, CA is seeking a Sr. Documentation Control Specialist to support the Quality Management System, document control activities, and QA operations. The role ensures accurate, inspection-ready documentation in alignment with GxP requirements.

You will partner with GMP and clinical quality teams, support CAPAs, deviations, change control, audits, training, and quality metrics. This is a hands-on, on-site role in a dynamic biotech startup.