Senior Cell Therapy QA Specialist

Organabio,-LL; San Diego (CA); On-site; USD 100,000 - 150,000; Full time

Job summary

OrganaBio is seeking a Cell Therapy Quality Assurance Specialist to support production in a GMP clean room environment at Excellos Labs in Downtown San Diego, CA. The role requires adherence to GMP standards, on-the-floor QA support, and collaborative cross-functional work to ensure quality and regulatory compliance.

The specialist will manage documentation, assist with deviations and CAPAs, and support audits and inspections while maintaining product integrity and confidentiality in a dynamic

Qualifications

• Degree in biology or related field or equivalent combination of education, training and/or experience.
• 5+ years of GMP Quality or Manufacturing experience; cell culture and aseptic processing preferred.
• Experience drafting and revising controlled documents; deviations, CAPA, and change control.

Responsibilities

• Adheres to GMP guidelines and trains team members.
• Provides on-the-floor QA support to manufacturing steps.
• Ensures aseptic processing and cleanroom protocols are followed.
• Reviews batch records for GMP compliance and disposition.
• Prepares for client audits and regulatory inspections.
• Supports CAPA, deviation investigations and change control.
• Collaborates with cross-functional teams and maintains confidentiality.

Skills

GMP knowledge

Cell culture

Aseptic technique

Documentation

CAPA

Change control

FDA/EMA regulations

Problem solving

Communication

Education

Biology degree

Job description

OrganaBio is seeking a Cell Therapy Quality Assurance Specialist to support production in a GMP clean room environment at Excellos Labs in Downtown San Diego, CA. The role requires adherence to GMP standards, on-the-floor QA support, and collaborative cross-functional work to ensure quality and regulatory compliance.

The specialist will manage documentation, assist with deviations and CAPAs, and support audits and inspections while maintaining product integrity and confidentiality in a dynamic