Senior Documentation & Quality Systems Lead

Socket.dev; South San Francisco (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Neurona Therapeutics in South San Francisco is seeking a Senior Documentation Control Specialist to manage GxP document control and quality system coordination within the QMS. You will ensure documents are accurate, inspection-ready, and compliant with GMP/GxP.

This role partners with GMP operations, clinical quality teams, and other functions to support audits, CAPAs, training, and metrics dashboards, while advancing training curriculums and document control processes in a fast-paced startup

Qualifications

• 5+ years in QA, quality systems, or document control in biotech/pharma.
• Experience in GxP environments incl. GCP/GMP support.
• Knowledge of document control processes and electronic Quality Management Systems (eQMS).
• Experience with audits, CAPAs, training management, controlled docs, inspection readiness, and metrics reporting.
• Proficient in Microsoft Excel or similar tools.
• Strong organizational, analytical, and problem-solving skills.
• Excellent written and verbal communication; able to work independently or cross-functionally.
• Willingness to grow in a dynamic startup environment.

Responsibilities

• Lead day-to-day document control activities within the electronic QMS, including creation, review, approval, issuance, revision, archival, and retirement of controlled documents (SOPs, forms, logs).
• Organize, maintain, and archive GxP documentation outside the QMS, ensuring inspection readiness and retrievability.
• Collaborate with GMP operations and clinical QA teams to support quality system activities.
• Support training curriculums, Deviation/CAPA, Change Control, and inspection readiness.
• Assist with internal and external audits, tracking status and follow-up actions.
• Develop and maintain quality metrics dashboards and trending tools for QA oversight and compliance monitoring.
• Collaborate cross-functionally to implement quality system improvements and ensure GxP compliance (GCP/GMP).
• Support document control room management and easy retrieval systems; train staff on access and system usage.
• Ensure data integrity and ALCOA++ adherence in GMP-regulated processes.

Skills

Quality Assurance

GxP

Document Control

eQMS

Audits

CAPAs

Training Management

Quality Metrics

GCP

GMP

Excel

Education

Bachelor's degree in scientific discipline

Tools

eQMS

Excel

Job description

Neurona Therapeutics in South San Francisco is seeking a Senior Documentation Control Specialist to manage GxP document control and quality system coordination within the QMS. You will ensure documents are accurate, inspection-ready, and compliant with GMP/GxP.

This role partners with GMP operations, clinical quality teams, and other functions to support audits, CAPAs, training, and metrics dashboards, while advancing training curriculums and document control processes in a fast-paced startup