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Artiva Biotherapeutics is a clinical-stage biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases. The lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies.
This role supports Quality Assurance Operations with primary focus on document control, records management, training management, and controlled labeling using Artiva's electronic Quality Management System (eQMS). You will ensure controlled documents, training records, labeling, logbooks, and quality records are accurate, current, traceable, and maintained in accordance with applicable procedures, regulatory requirements, and company standards.
Key responsibilities include:
- Perform day-to-day document control activities: reviewing document change requests for completeness and compliance, document review and formatting, assignment of training requirements, tracking, routing for approval, and release for use
- Support eQMS administration including user and workflow support, system record maintenance, and troubleshooting
- Support new hire onboarding by assigning training curricula, maintaining employee training plans, learner roles, and training assignments; lead annual employee training program review
- Maintain training programs and records for contractors and external service providers
- Coordinate drug product label issuance activities including request intake, label issuance, review, and reconciliation of controlled labeling records
- Issue controlled documents, equipment and facility logbooks, forms, and quality records to ensure current and traceable documentation
- Digitize and maintain paper records archival, storage, inventory, and retrieval processes
- Support internal, regulatory, and partner audits by retrieving records and preparing documentation
- Monitor periodic document review in eQMS and escalate as needed
- Provide guidance to document authors and reviewers on formatting, templates, and procedural requirements
- Attend production meetings representing QA Operations with functional updates on document status, metrics, and projects
- Follow FDA, ISO, ICH, EU GMP, and internal quality requirements
Requirements:
- Solid background in document control; prior experience with electronic quality management systems preferred
- 3+ years' experience in an FDA-regulated industry
- Strong proficiency in MS Office applications
- Able to lift boxes weighing up to 30 lbs
- Strong communication skills (verbal and written) with ability to interact positively across all organizational levels
- Ability to work independently
