GMP QA Specialist – Cell Therapy & Compliance

Austincc; California; Hybrid; USD 95,000 - 120,000; Full time

Job summary

Austincc is seeking a Specialist, Quality in Tarzana, CA to ensure compliance with the quality system and assess production and disposition of products. This role reports to QA management and supports multiple technical operations within the organization to maintain regulatory compliance.

The position focuses on routine QA responsibilities, deviations, CAPAs, change controls, and batch record review to ensure timely disposition and release of materials and finished products.

Qualifications

• Capable of leading deviations and investigations.
• Proficient with GMP and cGMP regulations.
• Experience writing and closing investigations and CAPAs.
• Knowledge of quality systems and regulatory requirements.

Responsibilities

• Provide QA support across Manufacturing, Facilities, Supply Chain, QC, Development and Tech.
• Lead deviations and investigations with cross-functional owners; drive CAPA and VoE closures.
• Manage phase-appropriate change controls for clinical stage products; support quality risk management.
• Provide ILT training for GMP/GDP, Quality Manual, and Change Control.
• Review batch records and QC data to support disposition and lot closure.

Skills

CAPA investigations

GMP compliance

Change control

Quality documentation

Education

MS in Biology/Chemistry/Microbiology/Engineering

BA/BS + 2 years QA experience

Job description

Austincc is seeking a Specialist, Quality in Tarzana, CA to ensure compliance with the quality system and assess production and disposition of products. This role reports to QA management and supports multiple technical operations within the organization to maintain regulatory compliance.

The position focuses on routine QA responsibilities, deviations, CAPAs, change controls, and batch record review to ensure timely disposition and release of materials and finished products.