Manufacturing Quality Specialist

Role Summary

The Manufacturing Quality Specialist will serve as the primary interface between Manufacturing (MG) and Quality, ensuring compliance, documentation accuracy, and continuous improvement across manufacturing operations. This role is responsible for quality event ownership, document control, training oversight, and data analysis to support CMC activities. The ideal candidate will demonstrate in-depth knowledge of cGMP compliance, be a self-starter, and can work independently to achieve corporate objectives. This is a full-time position reporting to the Associate Director of Manufacturing and located at Artiva’s headquarters in San Diego, CA.

Responsibilities

• Serve as the primary liaison between Manufacturing (MG) and Quality, ensuring alignment on quality expectations, investigations, and resolutions.
• Act as the primary author and owner of quality events, including Deviations, Corrective and Preventive Actions (CAPA), Nonconformance Material Reports (NCMR), and Change Controls.
• Manage and execute document revisions and lifecycle management of Manufacturing documents, including Master Batch Records (MBR), Equipment Procedures (EQT), Standard Operating Procedures (SOP), Standard Forms (SFM), Work Instructions (WRK), and Training Documents (TLT).
• Maintain training and qualification tracking for manufacturing and cleaning contract personnel.
• Author and review APV reports and other manufacturing quality documentation.
• Execute and support Master Batch Record (MBR) and logbook review to ensure completeness, accuracy, and compliance.
• Perform data tracking, analysis, and trending across CMC functions.
• Support continuous improvement initiatives by identifying trends, risks, and opportunities for process and compliance enhancement.

Qualifications

• Required: Minimum 5 years of experience in cGMP biologics or cell culture manufacturing.
• Required: Aseptic gowning and manufacturing in an ISO/Grade clean room environment.
• Required: Strong knowledge of GMP manufacturing and quality systems.
• Required: Excellent technical writing and documentation control skills.
• Required: Experience with quality investigations and root cause analysis.
• Required: Strong cross-functional communication and stakeholder management.
• Required: Data analysis and reporting skills.
• Required: Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Required: Willingness to think outside of the box and adapt best practices to a small, but growing environment.
• Required: Ability to adapt in a constantly evolving environment.
• Required: Self-motivated with a strong sense of ownership in areas of responsibility.
• Required: Excellent organizational skills and the ability to prioritize effectively to deliver results within reasonably established timelines.
• Preferred: Experience in biotech or cell therapy manufacturing is preferred.
• Preferred: Cell counting on various platforms.
• Preferred: Cell culture and expansion using bag systems, single-use large scale bioreactors, and others where applicable. Sartorius systems experience a plus.
• Preferred: Cell harvesting and washing processes, both automated and manual.
• Preferred: Cell selection and depletion techniques using Miltenyi CliniMACS Prodigy.
• Preferred: Fill finish and Cryopreservation processes and equipment.

Education

• Bachelor’s degree in relevant science or engineering discipline, or equivalent work experience.