Senior Associate, QA Compliance

Artiva Biotherapeutics • San Diego, CA

21d • $99,000 - $120,000

About The Position

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

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.

Nice To Haves

• Late-phase to commercial phase experience a plus.
• Cell Therapy experience a plus.

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.

Benefits

• 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
• Bonus.ly recognition program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior