Associate II, Quality Assurance Document Control

Artiva Biotherapeutics•San Diego, CA

8d•$75,000 - $90,000

About The Position

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell-killing properties of NK cells, when combined with mAbs for targeting, create an opportunity to generate potentially transformative therapies. This position is responsible for supporting Quality Assurance Operations activities at Artiva, with primary responsibilities for document control, records management, training management, and controlled labeling utilizing Artiva’s electronic Quality Management System. The role supports compliant and efficient quality system operations by ensuring controlled documents, training records, labeling, logbooks, and related quality records are accurate, current, traceable, and maintained in accordance with applicable procedures, regulatory requirements, and company standards.

Requirements

Solid background in document control, prior experience working 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 & written) including ability to interact positively with all levels of the organization
Ability to work independently

Nice To Haves

prior experience working with electronic quality management systems

Responsibilities

Perform day-to-day document control activities, including reviewing document change requests for completeness, accuracy, and compliance, document review, formatting, assignment of training requirements, tracking, routing for approval, and release for use.
Support administration of the electronic Quality Management System (eQMS), including user and workflow support, system record maintenance, and troubleshooting support as needed.
Support new hire onboarding activities by assigning required training curricula as well as maintaining and updating employee training plans, learner roles, and training assignments as well as leading the annual employee training program review.
Maintain training program 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.
Issuance of controlled documents, equipment and facility logbooks, forms, and related quality records to ensure current, accurate, and traceable documentation is available for use.
Digitize and maintain paper records archival, storage, inventory, and retrieval processes to support electronic recordkeeping and records management activities.
Support internal, regulatory, and partner audits by retrieving records, preparing requested documentation, and supporting timely follow-up activities.
Monitor periodic document review in the eQMS to ensure timely completion and escalation as needed.
Provide guidance to document authors and reviewers on document formatting, controlled template use, and procedural requirements.
Attend production meetings representing the QA Operations function and provide functional updates, including document status, metrics, and project updates.
Follow applicable regulations, standards, company policies, and procedures, including FDA, ISO, ICH, EU GMP, and internal quality requirements.
Support other Quality Assurance department needs and assigned activities as identified by management.