GeneFab · 4 months ago
Document Control & Training Manager
Alameda, CA
Full-time
Onsite
Mid, Senior Level
$115K/yr - $135K/yr
5+ years expGeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. The Document Control & Training Manager will lead document control activities and manage training-related tasks to support the Training Program, ensuring compliance with GxPs and Good Documentation Practices.
BiotechnologyInterior DesignManufacturing
Responsibilities
Manage, plan, and coordinate document control activities and processes, geared towards the quality and manufacturing organization
Lead Document Control compliance and process improvement efforts
Manage documentation by processing, formatting, issuing the documents for training, and making the process effective and accurate
Support the reconciliation and archiving process of paper documents
Responsible for reviewing Document Change Controls to ensure proper revision control of records and closure
Manage the document periodic review process and coordinate with the stakeholders on its completion
Perform Business Administrator activities in the electronic document management system (Veeva QualityDocs)
Execute user test scripts for the electronic document management system during changes to the systems
Manage Learner Roles, curriculums, and training requirements in the Learning Management System (Veeva Training)
Support onsite audits/ and or in any regulatory or client inspections
Perform other projects related to the improvement of quality systems as needed and required by management, including the Veeva eQMS system
Other related duties may be assigned or taken on as needed
Qualification
Required
Bachelor's degree or higher
Minimum 5-10 years of experience in a quality assurance role in the pharmaceutical industry required
Experience with EDMS and LMS systems, preferably Veeva Quality Docs and Veeva Training
Excellent knowledge and understanding of applicable GxP regulations
Experience in the identification and resolution of Good Documentation Practices issues
Familiarity with Microsoft Office Suite, DocuSign, Smartsheet, SharePoint, Adobe Pro, etc
Ability to work in a fast-paced environment with excellent multitasking skills
Must have attention to detail. Works with minimal supervision
Must have effective technical writing skills
Requires excellent organizational, interpersonal, and communication skills
Must exhibit professional behavior and be aware of the importance of teamwork within the assigned department
Preferred
Veeva Global Platform System Administration qualification/certification preferred
Company
GeneFab
GeneFab specializes in contract development, manufacturing, and synthetic biology for cell and gene therapies.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Philip Lee
Chief Executive Officer
Recent News
2025-05-17
Company data provided by crunchbase