Senior QC Microbiology Associate – Cell Therapy Startup

Theragent Inc.; Arcadia (CA); On-site; USD 41,000 - 55,000; Full time

Job summary

Theragent Inc. in Arcadia, CA is seeking a Senior Associate, QC Micro to help build and operate a CGMP-compliant QC Microbiology laboratory for cell and gene therapy products.

You will perform environmental monitoring, microbiological testing, and support for lot release, stability, and in-process samples, while ensuring precise documentation and regulatory compliance. The role requires strong microbiology knowledge, experience with CGMP and ICH guidelines, and ability to manage multiple tasks

Qualifications

• Knowledge of CGMP, ICH, pharmacopoeia and regulatory requirements for testing in the pharmaceutical industry is required.
• Experience in qualification of cell therapy equipment is preferred.
• Working knowledge of deviations, change controls and CAPAs.
• Basic knowledge of compendial requirements (USP/EP/JP) and related standards.

Responsibilities

• Perform environmental and utility monitoring of the CGMP facility under full gowning.
• Read plates, count colonies, and document results; review data with Lab Associate.
• Perform microbiology assays including bioburden and endotoxin testing.
• Support quarterly and annual reports, trend investigations, and quality statements.
• Assist with the qualification of lab equipment and GMP software systems.
• Assist in drafting SOPs, test methods, validations and deviations.

Skills

CGMP knowledge

ICH guidelines

Deviations/Change Controls

Documentation skills

Microbiology knowledge

Environmental monitoring

Aseptic processing

LIMS experience

MS Office

Communication skills

Education

Bachelor's degree in Microbiology

Tools

LIMS

Microbiology equipment

Microsoft Office

Job description

Theragent Inc. in Arcadia, CA is seeking a Senior Associate, QC Micro to help build and operate a CGMP-compliant QC Microbiology laboratory for cell and gene therapy products.

You will perform environmental monitoring, microbiological testing, and support for lot release, stability, and in-process samples, while ensuring precise documentation and regulatory compliance. The role requires strong microbiology knowledge, experience with CGMP and ICH guidelines, and ability to manage multiple tasks