Senior Document Control Specialist
Graphite Bio is a clinical-stage, next-generation gene editing company harnessing high efficiency targeted gene integration to develop a new class of therapies to potentially cure a wide range of serious and life-threatening diseases. Graphite Bio is pioneering a precision gene editing approach that could enable a variety of applications to transform human health through its potential to achieve one of medicine’s most elusive goals: to precisely “find & replace” any gene in the genome. Graphite Bio’s platform allows it to precisely correct mutations, replace entire disease-causing genes with normal genes or insert new genes into predetermined, safe locations. The company was co-founded by academic pioneers in the fields of gene editing and gene therapy, including Maria Grazia Roncarolo, M.D., and Matthew Porteus, M.D., Ph.D.
Graphite Bio is seeking a highly motivated Sr. Document Control Specialist that will be responsible for establishing, executing, and maintaining an efficient Document Management system that meets cGMP, GCP, and GLP requirements. This individual will play an essential role in providing oversight of the document control program and document management activities to assure compliance to the creation, review, approval, distribution, and retention of controlled documents and Quality Records.
This is a multidisciplinary role & this individual will interface across many parts of the company including process development, clinical operations, regulatory affairs, et al. to develop the best solutions possible. The successful candidate will be well versed in GMP documentation requirements and process development.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
What You Will Do:
- Provide leadership and independently perform Document Management activities, including, but not limited to: controlled document archiving and revisions, change record management and documents review for alignment to standards, accuracy, and completeness, Good Documentation Practices, and maintaining Standard Operating Procedures.
- Develop, oversee, and execute document control procedures including the creation, formatting, routing, review, approval, distribution, periodic review, and archiving of new and revised controlled documents
- Independently facilitate document initiation and revisions including formatting, coordinating the review and approval process, tracking and routing controlled documents, and releasing documents in the QMS in a timely manner
- Provide training on document control and record management systems, processes, and procedures
- Support implementation of an eDMS. Graphite Bio is focused on digital document management processes and electronic solutions for storage, transfer, and retrieval.
- Coordinate/ administrate documentation systems training
- Support new product introduction, production batch records change control, and BOM setup
- Review of documents for completeness, adherence to company guidelines for formatting, and review of authorization for approvals
- Ensure records are organized and maintained and support the implementation of quality systems in compliance with GxPs regulations and company policies
- Monitor of status of in-process document changes to ensure timely completion
- Maintains master documents and records as required by applicable regulations such that required documentation is retrievable and files are accurate, complete, and well organized
- Assists with maintaining systems to ensure integrity and security of all documents containing data relevant to product quality and/or quality systems
- Assist in quality audits including document preparation and record retrieval
- Support quality assurance product release as needed
- Create and maintain quality metrics reports
What You Will Bring:
- Bachelor's degree in a scientific discipline preferred
- 5+years of experience in Quality, Document Control
- Working knowledge of GxP record requirements
- Strong written and verbal communication skills and process
- Self-motivated and passionate about advancing the field of cell therapies
- Self-awareness, integrity, authenticity, and a growth mindset