Lead QC Microbiology Scientist & Mentor

FUJIFILM Electronic Materials (Europe) N.V.; North Carolina; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid vacation and holidays

Job summary

FUJIFILM Biotechnologies in North Carolina seeks a Lead Associate 3, Quality Control Microbiology to oversee complex microbiological testing and ensure CGMP compliance. You will train junior analysts, review technical data, and support audits while coordinating daily lab activities to ensure timely batch disposition.

The role requires strong aseptic technique, technical writing, and problem-solving skills, with flexibility to support a 24/7 manufacturing environment. On-site position near RTP.

Qualifications

• Bachelor’s degree in Life Science or related field with 4+ years CGMP experience.
• Experience with data management systems (LIMS, TrackWise).
• 6+ years CGMP Microbiology experience preferred.

Responsibilities

• Perform complex microbiological testing (Bioburden, Endotoxin, Culture Purity, Microbial IDs) per SOPs.
• Review data and author routine/periodic lab reports including EM trend reports.
• Support client audits and regulatory inspections as SME.
• Ensure CGMP compliance and laboratory inspection readiness.
• Lead deviations and investigations within quality systems.
• Mentor junior analysts and provide technical guidance.
• Schedule daily/weekly testing and manage workload with management.
• Participate in equipment qualification and validation activities.
• Troubleshoot equipment, assays, and methods with management support.

Skills

Aseptic techniques

Communication

Technical writing

Independent work

Prioritization

Collaboration

Pharmacopeia knowledge

Audit readiness

Lean six sigma

Data systems (LIMS)

Data systems (TrackWise)

Shift flexibility

Education

Bachelor’s degree in Life Science

Tools

LIMS

TrackWise

Job description

FUJIFILM Biotechnologies in North Carolina seeks a Lead Associate 3, Quality Control Microbiology to oversee complex microbiological testing and ensure CGMP compliance. You will train junior analysts, review technical data, and support audits while coordinating daily lab activities to ensure timely batch disposition.

The role requires strong aseptic technique, technical writing, and problem-solving skills, with flexibility to support a 24/7 manufacturing environment. On-site position near RTP.