QA Document Control Specialist – GMP & Training

artivabio; San Diego (CA); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, and Vision

Group Life Insurance

Long Term Disability (LTD)

401(k) Retirement Plan

Employee Assistance Program (EAP)

Flexible Spending Account (FSA)

Paid Time Off (PTO)

Year-end holiday week

Bonus.ly recognition program

Job summary

Artiva Biotherapeutics in San Diego is seeking a Quality Assurance Operations support professional focused on document control, records management, training management, and controlled labeling within Artiva’s eQMS. You will ensure accuracy, currency, traceability, and compliance of quality records across the organization.

The role supports audits, onboarding training, and continuous improvement of the quality system in a GMP environment, with opportunities to contribute to phase 3 development

Qualifications

• Associate’s degree or equivalent combination of education and experience.
• 3+ years’ experience in an FDA-regulated industry.
• Solid background in document control; experience 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).
• Ability to work independently.

Responsibilities

• Manage 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 activities by assigning required training curricula as well as 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.
• Issuance of 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 coordination of record box retrieval from the external records’ archival vendor facility.
• 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 supporting timely follow-up activities.
• Monitor periodic document review in the eQMS to ensure timely completion and escalation as needed.
• You will 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 in accordance with 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

Skills

Strong communication (verbal & written

Ability to work independently

Detail-oriented

Education

Associate's degree or equivalent

Tools

eQMS (electronic Quality Management System)

MS Office

Job description

Artiva Biotherapeutics in San Diego is seeking a Quality Assurance Operations support professional focused on document control, records management, training management, and controlled labeling within Artiva’s eQMS. You will ensure accuracy, currency, traceability, and compliance of quality records across the organization.

The role supports audits, onboarding training, and continuous improvement of the quality system in a GMP environment, with opportunities to contribute to phase 3 development