Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Sr. Documentation Control Specialist (Quality Systems) role.
Rezi rewrites your resume against Neurona Therapeutics's job description. Free.
Tailor your resume to this Sr. Documentation Control Specialist (Quality Systems) role.
Rezi rewrites your resume against Neurona Therapeutics's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Sr. Documentation Control Specialist (Quality Systems) posting at Neurona Therapeutics — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Sr. Documentation Control Specialist (Quality Systems) posting at Neurona Therapeutics — free, in seconds.
About the Role
Neurona is seeking a Senior Documentation Control Specialist to support the administration, organization, and continuous improvement of the Quality Management System (QMS). This role is a key resource for document control, quality systems coordination, and general QA operational support, ensuring quality documentation is accurate, organized, inspection ready, and maintained in accordance with company procedures and applicable GxP requirements.
Responsibilities
- Lead day-to-day document control activities within the electronic QMS, including development, formatting, review, approval, issuance, revision, archival, and retirement of controlled documents 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 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.
- Train staff on how to access documents or obtain system access.
- Ensure data integrity, ALCOA++ principles, and compliance with GMP regulations.
Requirements
- 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.
Skills
- Document control
- Quality Management System (QMS)
- GxP
- GCP
- GMP
- eQMS
- Audits
- CAPA
- Training management
- Controlled documentation
- Inspection readiness
- Quality metrics reporting
- Microsoft Excel
- Electronic tracking and reporting tools
- Technical writing
Location
- South San Francisco
Work Type
- Full-time
Experience Level
- Senior
Education Level
- Bachelor’s degree in scientific discipline or equivalent combination of education and relevant industry experience.
About the Company
- 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.
Equal Opportunity
- Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.