Senior QC Microbiology Analyst — Lead, Train & Improve GMP Lab

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior Analyst 1, QC Microbiology to lead key lab operations and train team members in microbial testing of drug substances, products, and materials. The role emphasizes independent work, adherence to SOPs, and collaboration with management on key decisions.

The position requires strong microbiology expertise, GMP knowledge, and experience with lab documentation and LEAN/six sigma principles.

Qualifications

• Bachelor’s degree with 2+ years of Microbiology experience or Master’s with 0 years.
• Experience with aseptic production and GMP environments.
• Knowledge of GMP/GLP/GDP requirements and lab testing.

Responsibilities

• Executes advanced lab testing and serves as SME and trainer for assays.
• Leads sample collection and manages logistics for testing.
• Supports qualification/validation protocols and sterility testing.
• Performs investigation of out-of-spec results and lab events.
• Writes and reviews documentation and manages project timelines.
• Supports audits and client interactions, and assists training of staff.

Skills

Microbiology

GMP

LEAN lab

Six Sigma

Documentation

Cross-functional work

Education

Bachelor’s degree in Microbiology or related

Master’s degree

Tools

LIMS

TrackWise

MALDI

MicroSeq

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior Analyst 1, QC Microbiology to lead key lab operations and train team members in microbial testing of drug substances, products, and materials. The role emphasizes independent work, adherence to SOPs, and collaboration with management on key decisions.

The position requires strong microbiology expertise, GMP knowledge, and experience with lab documentation and LEAN/six sigma principles.