Cell Therapy QA Specialist: GMP & Cleanroom Expert

American Bankruptcy Institute; San Diego (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

OrganaBio, operating through its Excellos Labs, LLC subsidiary in Downtown San Diego, is seeking a Cell Therapy QA Specialist to support production in a cGMP cleanroom environment and related QA activities. The role involves document management, material/product disposition, deviation/ CAPA processes, and audits with cross-functional teams.

The ideal candidate has a biology background with 5+ years in GMP/QM settings, strong aseptic technique, and experience drafting SOPs and controlled

Qualifications

• Degree in biology or related field or equivalent combination of education, training and/or experience.
• 5+ years industry experience with in a GMP Quality or Manufacturing environment; cell culture and aseptic processing experience preferred.

Responsibilities

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

Skills

GMP knowledge

Aseptic technique

Cleanroom gowning

Document drafting

CAPA & change control

Cell culture

Cross-functional collaboration

Attention to detail

Education

Biology degree

Tools

SOP drafting tools

Job description

OrganaBio, operating through its Excellos Labs, LLC subsidiary in Downtown San Diego, is seeking a Cell Therapy QA Specialist to support production in a cGMP cleanroom environment and related QA activities. The role involves document management, material/product disposition, deviation/ CAPA processes, and audits with cross-functional teams.

The ideal candidate has a biology background with 5+ years in GMP/QM settings, strong aseptic technique, and experience drafting SOPs and controlled