QA Compliance Associate II/III (Temp) – cGMP Biotech

Artiva Biotherapeutics Inc.; San Diego (CA); Presencial; USD 70.000 - 100.000; Jornada completa

Descripción de la vacante

Artiva Biotherapeutics is seeking a Temporary QA Compliance Associate II/III to support quality and cGMP compliance as we advance our cell therapies. You will review data, maintain records, and help ensure audits and regulatory compliance in a fast-paced biotech environment.

The role requires 3–5+ years in an FDA-regulated setting and a Bachelor’s degree, with level II/III distinctions based on experience. Join our growing Quality team to impact lot disposition, deviations, CAPAs, and change

Formación

• Bachelor’s degree or a combination of relevant education and applicable job experience
• 3+ years in an FDA-regulated industry and knowledge of cGMP regulations (Level II)
• 5+ years of progressively responsible experience in an FDA-regulated industry and demonstrated application of cGMP regulations (Level III)

Responsabilidades

• Review raw data and associated records for accuracy, completeness, traceability, and compliance with approved protocols, procedures, and applicable cGMP requirements.
• Maintain databases and metrics.
• Identify and communicate compliance gaps; propose phase-appropriate solutions.
• Perform routine status checks for quality events, including Deviations, CAPAs, SCARs, and Change Controls; follow up with responsible owners and elevate approaching or overdue due dates, as appropriate.
• Scan, file, and maintain controlled quality records in accordance with document control, records retention, and data integrity requirements.
• 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.

Educación

Bachelor's degree

Descripción del empleo

Artiva Biotherapeutics is seeking a Temporary QA Compliance Associate II/III to support quality and cGMP compliance as we advance our cell therapies. You will review data, maintain records, and help ensure audits and regulatory compliance in a fast-paced biotech environment.

The role requires 3–5+ years in an FDA-regulated setting and a Bachelor’s degree, with level II/III distinctions based on experience. Join our growing Quality team to impact lot disposition, deviations, CAPAs, and change