Senior Associate, QA Compliance
Artiva Biotherapeutics
4 months ago
Remote friendly (San Diego, CA)
United States
Operations
This position is responsible for Quality Assurance Compliance activities supporting deviations, CAPAs, change control, and product releases.
Responsibilities:
- Support deviation and CAPA/SCAR systems by investigating, reviewing, assessing, tracking, follow-up, and completing quality events.
- Support the Change Control program by reviewing, assessing, tracking, follow-up, and completing 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/procedures.
- Support other QA department needs as identified by management.
Qualifications / 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 (plus).
- Cell therapy experience (plus).
Benefits:
- Medical, Dental, Vision; Group Life Insurance; Long Term Disability (LTD); 401(k); EAP; FSA; Paid Time Off (PTO); company paid holidays (including year-end holiday week).
Responsibilities:
- Support deviation and CAPA/SCAR systems by investigating, reviewing, assessing, tracking, follow-up, and completing quality events.
- Support the Change Control program by reviewing, assessing, tracking, follow-up, and completing 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/procedures.
- Support other QA department needs as identified by management.
Qualifications / 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 (plus).
- Cell therapy experience (plus).
Benefits:
- Medical, Dental, Vision; Group Life Insurance; Long Term Disability (LTD); 401(k); EAP; FSA; Paid Time Off (PTO); company paid holidays (including year-end holiday week).