Associate II/III Quality Assurance Compliance - Temporary to Hire

Job Description

Job Description

About Artiva: 

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate,  AlloNK® , is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell-killing properties of NK cells, when combined with mAbs for targeting, create an opportunity to generate potentially transformative therapies.

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Join Artiva Biotherapeutics as a Temporary QA Compliance Associate II/III and play a key role in supporting quality and cGMP compliance as we advance our innovative cell therapies. We're seeking a detail-oriented quality professional with 3–5+ years of experience in an FDA-regulated environment who thrives in a fast-paced, collaborative biotech setting. Bring your compliance expertise, contribute to continuous improvement, and make a meaningful impact within our growing Quality team. Experience supporting Cell Therapy Manufacturing is a plus! You will be responsible for Quality Assurance Compliance activities supporting lot disposition, quality events, and development/qualification raw data review.

Responsibilities:

· 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 escalate 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.

Requirements:

· Bachelor’s degree or a combination of relevant education and applicable job experience

· Level II: 3+ years of experience in an FDA-regulated industry and knowledge of cGMP regulations. 

Level III: 5+ years of progressively responsible experience in an FDA-regulated industry and demonstrated application of cGMP regulations.