Temp QC Specialist: GMP Bioassays & ELISA/qPCR

BroadBean

California (MO)

On-site

USD 66,000 - 83,000

Full time

5 days ago

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Job summary

Bionova Scientific LLC in Fremont, CA seeks a motivated QC Specialist to join its rapidly growing team. You will contribute to QA/QC by performing bioassay tests, ELISA and qPCR, supporting method validation, and ensuring GMP-compliant documentation.

The role offers a pathway to influence testing strategies and patient outcomes. Qualified candidates have 5–7 years in bioassays/ELISA and 3–5 years in a regulated QC GMP lab, with strong data integrity and instrument proficiency (SpectraMax,

Qualifications

BS in Biological Sciences or related discipline is required or strongly preferred.
5–7 years of Bioassays and/or ELISA experience in regulated QC GMP labs.
3–5 years of experience in a GMP-regulated QC environment with data integrity.

Responsibilities

Perform cell-based assays, ELISA, and qPCR to support qualification and testing.
Develop, transfer, and validate analytical methods and bioassay processes.
Author and review method validation/qualification protocols and reports.
Maintain GMP documentation and ensure data integrity across studies.
Prepare buffers and maintain laboratory equipment and calibrations.
Manage inventory of reagents and support SOP adherence and CAPA processes.
Troubleshoot instrumentation and contribute to process improvements.