Quality Assurance Document Control Specialist

Artiva Biotherapeutics; San Diego (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Artiva Biotherapeutics in San Diego seeks a QA Document Control professional with 3+ years of GMP/regulatory experience to manage document lifecycle, training records, and controlled labeling using the eQMS. This role supports inspection readiness and records management across QA Operations.

You will review change requests, administer the eQMS, onboard new hires with training curricula, and coordinate labeling records while ensuring compliance with FDA, ISO, and company procedures.

Qualifications

• Solid background in document control and GMP/regulatory environments.
• Experience with electronic quality management systems preferred.
• Proficient in MS Office applications.

Responsibilities

• Perform day-to-day document control activities including change requests, review, training assignment, routing, and release.
• Support administration of the electronic Quality Management System (eQMS).
• Maintain training plans and onboarding activities for staff and contractors.
• Coordinate drug product label issuance and controlled labeling records.
• Digitize and archive paper records and support audits.

Skills

Document control

GMP/regulatory experience

MS Office

Communication skills

Tools

eQMS

Job description

Artiva Biotherapeutics in San Diego seeks a QA Document Control professional with 3+ years of GMP/regulatory experience to manage document lifecycle, training records, and controlled labeling using the eQMS. This role supports inspection readiness and records management across QA Operations.

You will review change requests, administer the eQMS, onboard new hires with training curricula, and coordinate labeling records while ensuring compliance with FDA, ISO, and company procedures.