Bioassay QC Analyst: Cell & Potency Testing

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a QC Analyst, Bioassay to execute cell- and plate-based analytical methods, including protein binding and cell-based potency assays, with maintenance of cell cultures and residual testing.

The role supports manufacturing and method transfers under GMP guidelines, and data is recorded in LIMS with cross-functional collaboration to ensure quality and regulatory compliance.

Qualifications

• Bachelor’s degree in life sciences or related field with 0–1 years' experience.
• Basic GMP/GLP understanding and familiarity with analytical testing methods.
• Experience with cellular and molecular assays such as ELISA, Dot Blot, PCR.

Responsibilities

• Executes cell- and plate-based analytical methods including protein binding and potency assays.
• Maintains cell culture and performs residual testing for DNA and HCP.
• Ensures data capture in LIMS and maintains data integrity.
• Supports QC method transfers and validations; assists with SOPs and CAPAs.
• Collaborates cross-functionally with QC, Manufacturing, Process Science and QA.

Skills

Cell culture

Protein binding assays

Cell-based assays

DNA/HCP testing

GMP knowledge

LIMS experience

Data integrity

Documentation

Education

Bachelor's degree in life sciences

Tools

LIMS software

Microsoft Excel

PowerPoint

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a QC Analyst, Bioassay to execute cell- and plate-based analytical methods, including protein binding and cell-based potency assays, with maintenance of cell cultures and residual testing.

The role supports manufacturing and method transfers under GMP guidelines, and data is recorded in LIMS with cross-functional collaboration to ensure quality and regulatory compliance.