Sr. Documentation Control Specialist (Quality Systems)Location: South San Francisco, CA, 94080
Job Type: Full Time
Work Type: On-Site
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
