QA Document Control Specialist: GMP Records & Training

Artiva Biotherapeutics Inc.

San Diego (CA)

On-site

USD 70,000 - 100,000

Full time

10 days ago
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Job summary

Artiva Biotherapeutics Inc. in San Diego is seeking a QA Document Control professional with 3+ years of GMP/regulatory experience to manage document lifecycle, training records, and controlled labeling within the company’s electronic Quality Management System (eQMS).

The role focuses on maintaining current, traceable quality records and supporting audits, with a hands-on approach to quality and strong attention to detail.

Qualifications

  • Solid background in document control and regulated environments.
  • 3+ years' experience in an FDA-regulated industry.
  • Strong proficiency in MS Office applications.
  • Able to lift boxes weighing up to 30 lbs.
  • Effective written and verbal communication; interacts well at all levels.
  • Ability to work independently.

Responsibilities

  • Perform day-to-day document control activities: change requests, review, formatting, training assignment, routing, approval, release.
  • Support eQMS administration, user/workflow support, and records maintenance.
  • Oversee onboarding training plans, annual program reviews, and training records for employees and contractors.
  • Coordinate labeling activities, including issuance and reconciliation of controlled labeling records.
  • Digitize, archive, and manage paper records to support electronic records management.

Skills

Strong communication
Independent worker

Tools

MS Office

Job description

Artiva Biotherapeutics Inc. in San Diego is seeking a QA Document Control professional with 3+ years of GMP/regulatory experience to manage document lifecycle, training records, and controlled labeling within the company’s electronic Quality Management System (eQMS).

The role focuses on maintaining current, traceable quality records and supporting audits, with a hands-on approach to quality and strong attention to detail.

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