Associate II, Quality Assurance Document Control

About Artiva

Artiva Biotherapeutics is a clinical‑stage biotechnology company focused on developing natural killer (NK) cell‑based therapies. Our mission is to create effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases, enabling use in community settings. Our lead product candidate, AlloNK®, is a non‑genetically modified, cryopreserved NK cell therapy evaluated in combination with B‑cell‑targeted monoclonal antibodies.

Responsibilities

• Perform day‑to‑day document control activities: review change requests for completeness, accuracy, and compliance; format documents; assign training requirements; track, route for approval, and release for use.
• Support administration of the electronic Quality Management System (eQMS), including user and workflow assistance, system record maintenance, and troubleshooting.
• Assist with new‑hire onboarding by assigning required training curricula, maintaining employee training plans, learner roles, and training assignments; lead the annual employee training program review.
• Maintain training programs and records for contractors and external service providers.
• Coordinate drug product label issuance: handle request intake, issue labels, review, and reconcile controlled labeling records.
• Issue controlled documents, equipment and facility logbooks, forms, and related quality records to ensure current, accurate, and traceable documentation.
• Digitize and maintain paper records, managing archival, storage, inventory, and retrieval to support electronic recordkeeping.
• Support internal, regulatory, and partner audits by retrieving records, preparing documentation, and facilitating timely follow‑up.
• Monitor periodic document review in the eQMS, ensuring timely completion and escalation as needed.
• Provide guidance to document authors and reviewers on formatting, template use, and procedural requirements.
• Represent QA Operations in production meetings, delivering updates on document status, metrics, and project progress.
• Follow applicable regulations, standards, and company policies, including FDA, ISO, ICH, EU GMP, and internal quality requirements.
• Support additional Quality Assurance department needs and assigned activities as directed by management.

Requirements

• Solid background in document control; experience with electronic quality management systems preferred.
• 3+ years of experience in an FDA‑regulated industry.
• Strong proficiency with Microsoft Office applications.
• Ability to lift boxes weighing up to 30 lb.
• Excellent verbal and written communication skills; ability to interact positively at all organizational levels.
• Ability to work independently.
• Other duties as assigned.