Associate II, Quality Assurance, Document Control

Job Description

Job Description

Salary: $75,000 - $90,000

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. For more information, visit

At Artiva, Your Quality Expertise Could Help Bring the Next Generation of Cell Therapies to Patients. This is more than document controlit's an opportunity to make a real impact at a Phase 3 clinical-stage biotherapeutics company on the path to commercialization. Join a collaborative Quality team where your work ensures the systems, documentation, and compliance that support life-changing therapies.If you're passionate about quality, thrive in a fast-paced GMP environment, and enjoy being the person who keeps everything organized, accurate, and inspection-ready, this is your chance to help build something meaningful.

In this role, you are responsible for supporting Quality Assurance Operations activities at Artiva, with primary responsibilities for document control, records management, training management, and controlled labeling utilizing Artivas 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.

Duties and 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 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

Requirements/Minimum Qualifications:

• Associates degree or a combination of relevant education and applicable job experience
• 3+ years experience in an FDA-regulated industry
• Solid background in document control, 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) including the ability to interact positively with all levels of the organization
• Ability to work independently
  

In addition to a great culture, we offer:

• A beautiful facility
• An entrepreneurial, highly collaborative, and innovative environment
• Comprehensive benefits, including:

• 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)
• Company paid holidays, including the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

If all this speaks to you, come join us on our journey!

Base Salary: $ 75,000 - $90,000. Exact compensation may vary based on level, skills and experience.

Affirmative Action/EEO statement

Artiva Biotherapeutics is an equal employment opportunity employer.