QC Microbiology Analyst I – Growth, Data & GMP

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

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking an Analyst 1, QC Microbiology to perform microbial testing of in-process drug substance, product, EM/UM, and raw materials under supervision. The role requires adherence to written procedures, data management, and contributor to document preparation and training.

Ideal candidates hold a life science degree with 0–1 year experience, understanding GMP/GDP, and possess meticulous attention to detail, problem-solving, and collaboration

Qualifications

• Bachelor's degree in a life science with 0–1 year experience.
• Understanding of GMP, GLP, GDP requirements.
• Basic technical writing and problem solving.

Responsibilities

• Supports environmental and utilities monitoring sample collection.
• Plans and ensures materials are stocked; coordinates with procurement.
• Performs advanced microbiology testing and analyzes Bioburden, Endotoxin.
• Conducts reviews of laboratory results and identifies trends.
• Maintains instruments and supports CAPAs.
• Assists with training and onboarding.

Skills

GMP knowledge

Microbiology testing

Data analysis

Documentation

Cross-functional

Education

Bachelor's degree in science

Tools

LIMS

TrackWise

MALDI

MicroSeq

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking an Analyst 1, QC Microbiology to perform microbial testing of in-process drug substance, product, EM/UM, and raw materials under supervision. The role requires adherence to written procedures, data management, and contributor to document preparation and training.

Ideal candidates hold a life science degree with 0–1 year experience, understanding GMP/GDP, and possess meticulous attention to detail, problem-solving, and collaboration