Bioassay QC Analyst: Cell-Based Potency & GMP Assurance

FUJIFILM; Holly Springs (NC); Vor Ort; USD 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

On-site facility

Zusammenfassung

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QC Analyst, Bioassay to execute cell- and plate-based analytical methods, including protein binding assays and cell-based potency assays. The role ensures GMP-compliant operations, generates results, and manages deviations, CAPAs, and laboratory exceptions while supporting method transfers and validations.

The position supports a fast-paced biotech environment and requires collaboration with Manufacturing, Process Science, and Quality

Qualifikationen

• Bachelor’s degree in life sciences or related field.
• 0-1 years of experience in QC or related role.
• Experience with cell culture and analytical testing methods.
• Knowledge of GMP/GLP/GDP requirements in biotech.

Aufgaben

• Execute cell- and plate-based analytical methods (e.g., ELISA, Dot Blot).
• Ensure GMP-compliant testing of in-process, DS, and DP samples.
• Capture data in LIMS and maintain data integrity.
• Identify deviations and implement CAPAs and improvements.
• Support method transfers and validations; author/review SOPs.

Kenntnisse

Cell culture

Bioassay

GMP knowledge

Data integrity

Cross-functional teamwork

Ausbildung

Bachelor’s degree in life sciences

Tools

LIMS software

Jobbeschreibung

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QC Analyst, Bioassay to execute cell- and plate-based analytical methods, including protein binding assays and cell-based potency assays. The role ensures GMP-compliant operations, generates results, and manages deviations, CAPAs, and laboratory exceptions while supporting method transfers and validations.

The position supports a fast-paced biotech environment and requires collaboration with Manufacturing, Process Science, and Quality