S'INSCRIRE
Retour aux emplois
XX
Senior Associate, QA ComplianceArtiva Biotherapeutics Inc. • San Diego, California, United States
Trouver des emplois similaires

Cette offre d'emploi n'est plus disponible

XX

Senior Associate, QA Compliance

Artiva Biotherapeutics Inc.
  • US
    San Diego, California, United States
  • US
    San Diego, California, United States
Trouver des emplois similaires

À propos

About Artiva: 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, creates an opportunity to generate potentially transformative therapies.
For more information, visit www.artivabio.com.
This position is responsible for Quality Assurance Compliance activities supporting deviations, CAPAs, change control, and product releases.
Duties/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 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.
Late-phase to commercial phase experience a plus.
Cell Therapy experience 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!
#J-18808-Ljbffr
  • San Diego, California, United States

Compétences linguistiques

  • English
Avis aux utilisateurs

Cette offre a été publiée par l’un de nos partenaires. Vous pouvez consulter l’offre originale ici.

Trouver des emplois similaires