GMP QC Specialist - Biologics Lab (Temporary)

Bionova Scientific, Inc.; Fremont (CA); On-site; USD 66,124 - 82,656; Full time

Job summary

Bionova Scientific LLC in Fremont, CA is seeking a motivated QC Specialist to join our growing biologics CDMO. In this role you will perform cell-based assays, ELISA, and qPCR to support method validation and in-process testing, ensuring accurate GMP documentation and data integrity.

The position is full-time, on-site in Fremont, with responsibilities spanning method transfer, instrument validation, and routine QA activities.

Qualifications

• BS in Biological Sciences or related discipline with GMP lab experience.
• 5–7 years in Bioassays/ELISA with regulatory QC exposure preferred.
• Proven skills in data integrity, documentation, and regulatory compliance.

Responsibilities

• Perform cell-based assays, ELISA, and qPCR supporting testing and stability studies.
• Develop, transfer, and validate analytical methods and instrument integration.
• Prepare and maintain GMP documentation and regulatory filings as needed.
• Troubleshoot analytical instruments and maintain quality systems adherence.
• Support SOPs, CAPA, deviations, and change controls; enable efficient QC operations.

Skills

Bioassay

ELISA

qPCR

SOPs

GMP

Data Integrity

SpectraMax

QuantStudio

CAPA

Change Control

Education

BS in Biological Sciences

Tools

SpectraMax

QuantStudio

Job description

Bionova Scientific LLC in Fremont, CA is seeking a motivated QC Specialist to join our growing biologics CDMO. In this role you will perform cell-based assays, ELISA, and qPCR to support method validation and in-process testing, ensuring accurate GMP documentation and data integrity.

The position is full-time, on-site in Fremont, with responsibilities spanning method transfer, instrument validation, and routine QA activities.