Lead QC Microbiology Scientist — Mentor & GMP Expert

FUJIFILM Holdings America Corporation; North Carolina; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement plan

Paid time off and holidays

Professional growth opportunities

Job summary

FUJIFILM Holdings America Corporation — located near Morrisville and RTP, NC — seeks a Lead Associate 3, Quality Control Microbiology to oversee complex microbiology testing, train junior analysts, and ensure timely batch disposition with high accuracy.

The role requires CGMP microbiology experience, strong data management skills, and the ability to lead investigations and support regulatory inspections within a collaborative, on-site lab environment.

Qualifications

• Bachelor’s degree in Life Science or related field with 4+ years CGMP microbiology experience.
• Experience with data management systems (LIMS, TrackWise) is required.
• CGMP microbiology laboratory experience and audit readiness are essential.

Responsibilities

• Performs complex microbiological testing (e.g., Bioburden, Endotoxin, Culture Purity, ID) per SOPs.
• Reviews data and authors routine lab reports including EM trend reports.
• Supports audits and regulatory inspections as SME for assays/methods.
• Maintains CGMP compliance and data integrity in the lab.
• Leads deviations, investigations, and project developments from concept to execution.
• Mentors junior analysts and provides technical guidance.

Skills

Aseptic techniques

Technical writing

Problem solving

Independent work

Team collaboration

Audit readiness

Data management systems

CGMP knowledge

Education

Bachelor’s in Life Science or related field

Tools

LIMS

TrackWise

Job description

FUJIFILM Holdings America Corporation — located near Morrisville and RTP, NC — seeks a Lead Associate 3, Quality Control Microbiology to oversee complex microbiology testing, train junior analysts, and ensure timely batch disposition with high accuracy.

The role requires CGMP microbiology experience, strong data management skills, and the ability to lead investigations and support regulatory inspections within a collaborative, on-site lab environment.