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 is seeking a Cell Therapy Quality Assurance Specialist to support production of cellular products in a cGMP clean room. The role covers document management, material disposition, deviation and CAPA approvals, and storage and distribution oversight.

You will work in ISO7/ISO8 spaces, ensure aseptic techniques, draft and revise SOPs and batch records, participate in client audits and regulatory inspections, and partner with cross-functional teams.

Qualifications

• Degree in biology or related field
• 5+ years industry experience in GMP Quality or Manufacturing
• Cell culture and aseptic processing experience preferred
• Experience drafting/revising controlled documents and handling deviations/CAPA/change control

Responsibilities

• Adheres to GMP guidelines and trains team members
• Provides on-the-floor QA support to manufacturing teams
• Ensures aseptic processing techniques and cleanroom behavior
• Reviews batch records for GMP compliance and disposition
• Supports client audits and regulatory inspections
• Participates in CAPA, deviation, and change control processes
• Collaborates with cross-functional teams and maintains confidentiality

Skills

GMP knowledge

Aseptic processing

Cleanroom gowning

Documentation control

Deviation CAPA handling

Cell culture knowledge

Regulatory compliance

Education

Degree in biology or related field

Tools

SOP drafting

BPR documentation

QA record review

Job description

OrganaBio, LLC in San Diego is seeking a Cell Therapy Quality Assurance Specialist to support production of cellular products in a cGMP clean room. The role covers document management, material disposition, deviation and CAPA approvals, and storage and distribution oversight.

You will work in ISO7/ISO8 spaces, ensure aseptic techniques, draft and revise SOPs and batch records, participate in client audits and regulatory inspections, and partner with cross-functional teams.