QC Specialist, Biologics GMP Lab (ELISA/qPCR)

Bionova Scientific; 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 expanding QC team. You will perform bioassays, ELISA, and qPCR testing and contribute to method qualification, transfer, and validation to ensure patient safety and regulatory compliance.

Ideal candidates have a BS in Biological Sciences with 5–7 years in a GMP QC environment, hands-on with Bioassay/ELISA/qPCR, and strong documentation skills using GDP and ALCOA+ principles.

Qualifications

• BS in Biological Sciences or related discipline.
• 5–7 years of Bioassays/ELISA experience in a GMP QC setting.
• Proficiency with GMP documentation and regulatory compliance.

Responsibilities

• Perform cell-based assays, ELISA, and qPCR testing to support QC activities.
• Develop, transfer, and validate analytical methods (Bioassay, ELISA, qPCR).
• Author and review technical documents and regulatory filings as needed.
• Maintain GMP documentation and participate in SOPs and quality systems.

Skills

Bioassays

ELISA

qPCR

Written communication

Data interpretation

Analytical skills

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 expanding QC team. You will perform bioassays, ELISA, and qPCR testing and contribute to method qualification, transfer, and validation to ensure patient safety and regulatory compliance.

Ideal candidates have a BS in Biological Sciences with 5–7 years in a GMP QC environment, hands-on with Bioassay/ELISA/qPCR, and strong documentation skills using GDP and ALCOA+ principles.