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Senior Associate, QA Compliance
- San Diego, California, United States
- San Diego, California, United States
About
For More Information Visit www.artivabio.com.
This Position 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.
Benefits
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!
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Languages
- English
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