Bioassay QC Analyst — GMP Cell & Potency Testing

FUJIFILM

Holly Springs (NC)

On-site

USD 55,000 - 75,000

Full time

6 days ago

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Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a QC Analyst, Bioassay to execute cell- and plate-based analytical methods, maintain cell culture, and perform residual testing for DNA, HCP, and Protein A/G. This role ensures GMP-compliant laboratory operations and data integrity in LIMS, while supporting method transfers and validations.

You will work with Manufacturing, Process Science, and QA to drive quality, CAPAs, and continuous improvement, with flexibility to support 24/7

Qualifications

Bachelor’s degree in life sciences or related field with 0–1 year experience.
Basic GMP, GLP, GDP understanding.
Experience with cellular and molecular analytical testing.
Experience performing QC testing (cell culture, PCR, ELISA, Dot Blots).

Responsibilities

Execute cell- and plate-based analytical methods (ELISA, Dot Blot, etc.) and cell-based potency assays.
Ensure GMP-compliant testing of in-process, DS/DP, and stability samples.
Capture data in LIMS and maintain data integrity.
Report assay performance and implement improvements; address excursions and CAPAs.
Support QC Bioassay lab activities and method transfers/validations.