Sr. Documentation Control Specialist (Quality Systems)

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

Sr. Documentation Control Specialist (Quality Systems)

Neurona Therapeutics is a clinical stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for neurological diseases. Our ideal candidate is a self-motivated individual who has a passion for quality. This is a fantastic opportunity to join a growing team, and take part in building an exciting, science-driven company.

The role:

Neurona is seeking a Senior Documentation Control Specialist, GxP Document Control and Quality Systems to support the administration, organization, and continuous improvement of the Quality Management System (QMS). This role serves as a key resource for document control, quality systems coordination, and general QA operational support. Core to this work is ensuring quality documentation is accurate, organized, inspection ready, and maintained in accordance with company procedures and applicable GxP requirements.

Responsibilities include:

• Lead day-to-day document control activities within the electronic QMS, including development, formatting, review, approval, issuance, revision, archival, and retirement of controlled documents (SOPs, forms, templates, logs, etc.) in accordance with company procedures and applicable GxP requirements.
• Organize, maintain, and archive GxP documentation that exists outside the formal QMS structure, ensuring it is inspection ready and easily retrievable.
• Serve as a key operational support resource for the GxP QMS function, partnering closely with the GMP operations and clinical GCP quality teams to support quality system activities across the organization.
• Support the continued development and maintenance of the training curriculums and GxP tracking, support administration of Deviation/CAPA support, Change Control, and inspection readiness.
• Support internal and external audit scheduling and logistics, track audit status, and assist with follow-up activities as needed.
• Support the development and maintenance of quality metrics dashboards, trackers, and trending tools to support QA operational oversight, compliance monitoring, and continuous improvement initiatives.
• Collaborate cross-functionally with Quality and other departments to support ongoing quality system improvements and ensure compliance with applicable GxP requirements, including GCP and GMP activities.
• Support additional quality systems initiatives and operational activities.
• Support the management of the document control room and develop a system for easy retrieval of documents.
• Training staff on how to access documents or obtain system access.
• Ensure data integrity, ALCOA++ principles, and compliance with GMP regulations.

Required Qualifications:

• Minimum 5+ years of experience in Quality Assurance, Quality Systems, or Document Control within the biotechnology, pharmaceutical, or other regulated industry.
• Experience working within GxP-regulated environments, including support of GCP and/or GMP quality system activities.
• Working knowledge of document control processes and electronic Quality Management Systems (eQMS).
• Experience supporting quality systems activities such as audits, CAPAs, training management, controlled documentation, inspection readiness, and quality metrics reporting.
• Strong proficiency in Microsoft Excel or similar electronic tracking and reporting tools.
• Strong organizational, analytical, and problem-solving skills with the ability to manage multiple priorities and timelines in fast paced environment.
• Strong attention to detail with the ability to work both independently and collaboratively across functions.
• Excellent written and verbal communication skills.
• Willingness to expand skill set and contribute to emerging needs in a highly dynamic start-up environment

Preferred Qualifications:

• Bachelor’s degree in scientific discipline or equivalent combination of education and relevant industry experience.
• Experience in technical writing is a plus.
• Experience in clinical-stage biotechnology or pharmaceutical environments preferred.

Interested in learning more about our science and our team? Please visit our website at www.neuronatherapeutics.com

Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.