Lead QC Microbiology Specialist (8am–5pm)

FUJIFILM Holdings America Corporation; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan

Paid vacation

Career growth opportunities

Job summary

FUJIFILM Biotechnologies in North Carolina seeks a Lead Associate 3, Quality Control (QC) Microbiology to oversee microbiology testing and train junior analysts, ensuring right-the-first-time batch disposition.

This role requires CGMP compliance, data integrity, and collaboration with management to escalate technical issues and drive continuous improvement in lab operations.

The position is based at the Morrisville/RTP site with a daytime shift and a team focused on bioscience breakthroughs.

Qualifications

• Bachelor’s degree in Life Science with 4+ years CGMP experience.
• Experience with data management systems (LIMS/TrackWise).
• Strong understanding of US Pharmacopeia and European Pharmacopeia.

Responsibilities

• Perform complex microbiological testing (Bioburden, Endotoxin, Culture Purity).
• Review data and author routine lab reports and EM trend reports.
• Support audits and regulatory inspections as SME.
• Ensure CGMP compliance and data integrity in the lab.
• Lead deviations investigations with management.
• Mentor junior analysts and provide technical guidance.
• Participate in equipment qualification and validation.

Skills

Aseptic techniques

Communication

Technical writing

Independent work

Project coordination

Data management systems

Lean six sigma

Collaboration

Audits/regulatory readiness

Education

Bachelor's degree in Life Science

Tools

LIMS

TrackWise

Job description

FUJIFILM Biotechnologies in North Carolina seeks a Lead Associate 3, Quality Control (QC) Microbiology to oversee microbiology testing and train junior analysts, ensuring right-the-first-time batch disposition.

This role requires CGMP compliance, data integrity, and collaboration with management to escalate technical issues and drive continuous improvement in lab operations.

The position is based at the Morrisville/RTP site with a daytime shift and a team focused on bioscience breakthroughs.