Senior QA Compliance Specialist - Deviation & Change

Artiva Biotherapeutics; San Diego (CA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) Retirement Plan

Flexible Spending Account (FSA)

Job summary

Artiva Biotherapeutics is seeking a Quality Assurance professional responsible for compliance activities supporting deviations, CAPAs, change control, and product releases. The ideal candidate has over 5 years of experience in an FDA regulated industry and a Bachelor’s degree.

This role includes supporting deviation investigations, maintaining metrics, and tracking compliance gaps, while working in a beautiful facility within a collaborative environment.

Comprehensive benefits include Medical, Dental, and Vision, along with 401(k) Retirement Plan and Paid Time Off.

Qualifications

• 5+ years’ experience in an FDA regulated industry.
• Late-phase to commercial phase experience is a plus.
• Cell Therapy experience is a plus.

Responsibilities

• Support the deviation and CAPA/SCAR Systems.
• Maintain databases and metrics.
• Identify and communicate compliance gaps.
• Track the status of Deviations, CAPAs, and Change Controls.
• Perform internal and/or external audits as needed.

Skills

Quality Assurance Compliance

Investigating quality events

CAPA/SCAR Systems

Change Control

Internal/External Audits

FDA regulations

CGMP regulations

Education

Bachelor’s degree or relevant education

Job description

Artiva Biotherapeutics is seeking a Quality Assurance professional responsible for compliance activities supporting deviations, CAPAs, change control, and product releases. The ideal candidate has over 5 years of experience in an FDA regulated industry and a Bachelor’s degree.

This role includes supporting deviation investigations, maintaining metrics, and tracking compliance gaps, while working in a beautiful facility within a collaborative environment.

Comprehensive benefits include Medical, Dental, and Vision, along with 401(k) Retirement Plan and Paid Time Off.