Associate II, Quality Assurance, Document Control

Job Overview In this role, you are responsible for supporting Quality Assurance Operations activities, primarily overseeing document control, records management, training management, and controlled labeling using the company’s electronic Quality Management System. Your work ensures 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. 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 new hire onboarding by assigning required training curricula and maintaining and updating employee training plans, learner roles, and training assignments. Maintain training program and records for contractors and external service providers. Coordinate DP, ICB, and eHuT label issuance activities, including request intake, label issuance, review, and reconciliation of controlled labeling records. Issue controlled documents, equipment and facility logbooks, forms, and related quality records to ensure current, accurate and traceable documentation is available for use. Maintain paper records archival, storage, inventory, and retrieval processes, including coordinating record box retrieval from external records’ archival vendor facilities. Digitize paper records, including material release files, logbooks and other quality records, as needed to support electronic recordkeeping and records management activities. Support internal, regulatory and partner audits by retrieving records, preparing requested documentation, and facilitating 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, revision history expectations, controlled template use and procedural requirements. Identify and communicate documentation, training, labeling or records management issues to management and support resolution per applicable procedures. 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. Other duties as assigned. Qualifications Associate’s degree or a combination of relevant education and applicable job experience. 3+ years’ experience in an FDA‑regulated industry. Solid background in document control, with prior experience working with electronic quality management systems preferred. Strong proficiency in MS Office applications. Able to lift boxes weighing up to 30 lbs. Strong communication skills (verbal & written) and the ability to interact positively with all levels of the organization. Ability to work independently. Affirmative Action / EEO Statement Artiva Biotherapeutics is an equal employment opportunity employer. #J-18808-Ljbffr Artiva Biotherapeutics Inc.