Cell Therapy QA Specialist: GMP & Cleanroom Expert

OrganaBio, LLC; San Diego (CA); On-site; USD 44,000 - 51,000; Full time

Job summary

OrganaBio, LLC in San Diego, CA, is seeking a Cell Therapy Quality Assurance Specialist to support cGMP cell manufacturing in a clean room environment at Excellos Labs.

You will perform QA support, document management, deviation and CAPA processing, and assist with audits, training, and cross-functional collaboration.

The role requires a biology degree and 5+ years GMP experience, with aseptic processing and SOP/document control expertise, reporting to QA leadership.

Qualifications

• Education: Biology degree or equivalent.
• Experience: 5+ years in GMP Quality or Manufacturing, cell culture and aseptic processing preferred.
• Skills: GMP, aseptic techniques, SOPs and documentation control, CAPA, change control.

Responsibilities

• Adheres to GMP guidelines and trains team members.
• On-floor QA support for manufacturing processes, deviations and incidents.
• Ensure aseptic processing techniques and cleanroom behavior.
• Review batch records for GMP compliance and disposition.
• Assist with client audits and regulatory inspections.
• Draft/revise controlled documents and SOPs.

Skills

GMP knowledge

Aseptic technique

Cell culture

SOP drafting

CAPA & change control

Documentation

Cross-functional collaboration

Attention to detail

Education

Biology degree

Job description

OrganaBio, LLC in San Diego, CA, is seeking a Cell Therapy Quality Assurance Specialist to support cGMP cell manufacturing in a clean room environment at Excellos Labs.

You will perform QA support, document management, deviation and CAPA processing, and assist with audits, training, and cross-functional collaboration.

The role requires a biology degree and 5+ years GMP experience, with aseptic processing and SOP/document control expertise, reporting to QA leadership.