QC Specialist – Bioassay & ELISA (GMP Lab)

Asahi Kasei; Fremont (CA); On-site; USD 66,000 - 83,000; Full time

Job summary

Bionova Scientific LLC in Fremont, California is seeking a motivated QC Specialist to contribute to our expanding QC team. You will perform cell-based assays, ELISA, and qPCR to support method qualification, release, and stability studies while ensuring GMP documentation and regulatory compliance.

The role requires a BS in Biological Sciences with 5–7 years of Bioassays/ELISA experience and 3–5 years in a GMP QC laboratory.

Qualifications

• BS in Biological Sciences or related discipline.
• 5–7 years of Bioassays and/or ELISA experience; 3–5 years in a regulated QC GMP lab.
• Proficiency with Bioassay, ELISA, qPCR; strong documentation and GMP compliance.
• Experience with SPECS: SpectraMax and QuantStudio instruments.
• Ability to follow SOPs, protocols, and regulatory requirements.

Responsibilities

• Perform cell-based assays, ELISA, and qPCR testing to support method qualification, in-process testing, release, and stability studies with GMP documentation.
• Participate in development, transfer, and validation of analytical/test methods (Bioassay, ELISA, qPCR).
• Author and review technical documents including method validation/qualification protocols and reports.
• Maintain QC documentation, logbooks, and data records with accuracy and compliance.
• Perform routine equipment maintenance per established procedures.
• Identify and implement process improvements to enhance efficiency and robustness of bioassay testing.

Skills

Bioassays

ELISA

qPCR

SOPs

Regulatory compliance

GDP

Data Integrity

ALCOA+

SpectraMax

QuantStudio

Microsoft Office

Education

BS in Biological Sciences

Tools

SpectraMax

QuantStudio

Job description

Bionova Scientific LLC in Fremont, California is seeking a motivated QC Specialist to contribute to our expanding QC team. You will perform cell-based assays, ELISA, and qPCR to support method qualification, release, and stability studies while ensuring GMP documentation and regulatory compliance.

The role requires a BS in Biological Sciences with 5–7 years of Bioassays/ELISA experience and 3–5 years in a GMP QC laboratory.