Cell Therapy QA Specialist: GMP & Cleanroom Expert

OrganaBio; San Diego (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

OrganaBio is seeking a Cell Therapy Quality Assurance Specialist to support the production of cellular products in a cGMP environment at Excellos Labs in Downtown San Diego, CA. The role focuses on QA support, document management, and disposition of materials and products to ensure GMP compliance and readiness for audits and inspections.

The ideal candidate has a biology degree and 5+ years of GMP experience, with hands-on cell culture and aseptic processing knowledge, ready to work in a

Qualifications

• Bachelor's degree in biology or related field required.
• 5+ years of GMP quality or manufacturing experience.
• Experience with cell culture and aseptic processing.

Responsibilities

• Adheres to GMP guidelines and trains team on GMP practices.
• Provides on-floor QA support to manufacturing teams.
• Manages document control, batch records, and disposition reviews for GMP compliance.
• Supports deviation, CAPA, and change control processes.
• Prepares for client audits and regulatory inspections.
• Collaborates with cross-functional teams to improve processes and documentation.

Skills

Aseptic technique

GMP compliance

Cell culture

Documentation drafting

Change control

Education

Biology degree or related field

Tools

SOP drafting

Job description

OrganaBio is seeking a Cell Therapy Quality Assurance Specialist to support the production of cellular products in a cGMP environment at Excellos Labs in Downtown San Diego, CA. The role focuses on QA support, document management, and disposition of materials and products to ensure GMP compliance and readiness for audits and inspections.

The ideal candidate has a biology degree and 5+ years of GMP experience, with hands-on cell culture and aseptic processing knowledge, ready to work in a