Quality Assurance Associate, Materials Job at Artiva Biotherapeutics

Artiva Biotherapeutics San Diego, CA 92121

About Artiva:

Artiva’s mission is to deliver highly effective, off-the-shelf, allogeneic NK cell-based therapies utilizing our Manufacturing-First approach, that are safe and accessible to cancer patients. Artiva’s pipeline includes AB-101, an ADCC enhancer NK-cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva is currently advancing a Phase 1/2 clinical trial of AB-101 in combination with rituximab for the treatment of relapsed or refractory B-cell lymphomas. Artiva’s pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-overexpressing tumors, such as breast, gastric, and bladder cancers, and for which an IND has been allowed by FDA, and a pipeline of CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva has entered into therapeutic NK cell collaborations with Merck Sharp & Dohme Corp. and with Affimed GmbH. Artiva’s AlloNK™ platform incorporates cell expansion, activation, and engineering technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea. Artiva is headquartered in San Diego.


Job Summary:

This position is responsible for Quality Materials activities at Artiva with key responsibilities including Materials Disposition and administer the Nonconforming Materials process including the initiation of SCARs, Deviations, and QA Holds, as required. This position will perform document control duties, some in-process batch record reviews and troubleshoot low level issues.


The Location:

Artiva Headquarters in San Diego, CA


What you'll do:

  • Perform day to day materials release functions, including documentation review, physical inspections, and disposition processes
  • Collaborate with Materials Management, and other functional areas, to ensure effective and timely disposition of incoming materials
  • Identify and initiate NCMRs, Deviations, QA Holds and SCARs, when applicable
  • Identify and administer change and process improvement initiatives
  • Assist in the implementation of new quality systems
  • Perform Document Control functions as assigned by management
  • Participate in audits by regulatory or state agencies and partners
  • Follow applicable regulations, including FDA, ISO, ICH, and company policies and procedures.
  • Support other QA department needs as identified by management.

What you will bring:

  • Associates degree or a combination of relevant education and applicable job experience
  • 3+ years’ experience in an QA or a combination of QA and Materials Management
  • 5+ years’ experience in an FDA regulated industry
  • Solid background in materials dispositions
  • Strong Proficiency in MS Word
  • Prior experience working with electronic quality management systems

Why you should apply

We have a fantastic team and philosophy! We are passionate – we deeply care about our team, our science, and improving the lives of cancer patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.


In addition to a great culture, we offer:

  • A beautiful new 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!


Artiva Biotherapeutics is an equal employment opportunity employer.


Base Salary: $65,000 - $85,000. Exact compensation may vary based on skills and experience.




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