Bioassay QC Analyst: Cell-Based Potency & GMP

FUJIFILM

Holly Springs (AL)

On-site

USD 60,000 - 80,000

Full time

12 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 and ensure GMP-compliant operations. The role involves routine testing for DS/DP/stability, CAPAs, and cross-functional collaboration with QA, Manufacturing, and Process Science.

The candidate will perform transfers and validations, support 24/7 manufacturing, and contribute to SOP development and deviations investigations.

Qualifications

Bachelor’s degree in life sciences with 0-1 years of experience.
Basic understanding of GMP, GLP, GDP requirements.
Experience with cellular and molecular analytical testing methods.
Experience performing QC testing involving cell culture, PCR, ELISA, Dot Blots, etc.

Responsibilities

Executes cell- and plate-based analytical methods including protein binding assays and cell-based potency assays.
Ensures testing of in-process, DS, DP and stability samples complies with GMP.
Captures data in LIMS and maintains data integrity.
Reports assay performance and assists with CAPAs and improvements.
Supports QC Bioassay lab activities and method transfers/validations.
Assists with authoring and reviewing QC SOPs.