QC Associate I – Bioassay & Cell-Based Testing

1000 Genentech, Inc.; South San Francisco (CA); On-site; USD 61,000 - 113,000; Full time

Job summary

Genentech, a Roche company in South San Francisco, is seeking a Quality Control Associate I for the Bioassay US Testing Group. You will perform biochemical and cell-based assays to support clinical and commercial products and contribute to cGMP compliant operations.

You will review data, prepare reagents, maintain data integrity with GDP/ALCOA++, and collaborate across teams while advancing your technical and analytical skills in biopharmaceuticals.

Qualifications

• Bachelor’s degree in Biological Sciences or related field.
• Experience in a Quality Control or GxP laboratory environment is preferred.
• Hands-on experience with cell-based and non-cell-based assays.

Responsibilities

• Perform biochemical and immunological cell-based and non-cell-based assays to support clinical and commercial products.
• Support critical operations including process development, product characterization, stability studies, in-process testing, and lot release testing within a cGMP environment.
• Review and release assay data across electronic and paper formats while maintaining high compliance standards.
• Prepare laboratory reagents, monitor assay performance, and present quality results to cross-functional teams.
• Uphold data integrity and quality standards by applying GDP and ALCOA++ principles.
• Maintain high lab standards by participating in EHS practices, 5S, and routine equipment upkeep.
• Leverage quality systems and lab informatics including LIMS, ELN, and document management platforms.

Skills

Cell-based assays

Non-cell-based assays

cGMP standards

GDP/ALCOA

Cross-functional communication

Education

Bachelor’s degree in Biological Sciences or related field

Tools

SoftMax Pro

LIMS

ELN

Veeva QMS

Job description

Genentech, a Roche company in South San Francisco, is seeking a Quality Control Associate I for the Bioassay US Testing Group. You will perform biochemical and cell-based assays to support clinical and commercial products and contribute to cGMP compliant operations.

You will review data, prepare reagents, maintain data integrity with GDP/ALCOA++, and collaborate across teams while advancing your technical and analytical skills in biopharmaceuticals.