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Sr. Associate, Quality Assurance, Compliance

Artiva Biotherapeutics

Artiva Biotherapeutics

Legal, Quality Assurance
San Diego, CA, USA
Posted on Tuesday, May 28, 2024

About Artiva

Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Our lead program, AlloNK®, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers. AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed’s innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas

Position Summary:

This position is responsible for Quality Assurance Compliance activities supporting deviations, CAPAs, change control, product releases, and risk assessments.

Role & Responsibilities:

  • Support the deviation and CAPA/SCAR Systems by investigating, reviewing, assessing, tracking, follow-up, and completing all quality events.
  • Support the Change Control program by reviewing, assessing, tracking, follow-up, and completing all change control documentation.
  • Maintain databases and metrics.
  • Identify and communicate compliance gaps; propose phase appropriate solutions.
  • Track the status of Deviations, CAPAs, and Change Controls.
  • Perform internal and/or external audits, as needed.
  • Support product releases by reviewing batch records.
  • Support data integrity validation planning and execution.
  • Support data integrity continuous improvement initiatives.
  • Track data integrity activities.
  • Support risk assessment activities.
  • Support 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.

Requirements:

  • Bachelor’s degree or a combination of relevant education and applicable job experience
  • 5+ years’ experience in an FDA regulated industry and CGMP regulations.
  • Familiarity with implementing/supporting Risk Assessment program a plus.

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!

Artiva Biotherapeutics is an equal employment opportunity employer.

Base Salary: $95,000 -$115,000. Exact compensation may vary based on position level, skills and experience.