Senior QC Instrumentation Specialist: Data Integrity

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Holdings America Corporation in North Carolina is seeking a Sr. Specialist 2, QC Instrumentation to own the lifecycle of analytical instruments in a high‑impact quality control team.

You will lead qualification, routine operation, maintenance, continuous improvement, and decommissioning with minimal supervision while ensuring data integrity and regulatory compliance. You will partner with cross‑functional teams and external vendors to solve complex problems, drive improvements, and

Qualifications

• Bachelor’s degree in a related science with 5+ years of GMP experience.
• Master’s degree in a related science with 3+ years of experience.
• PhD in a related science with 1+ year of experience.
• Minimum 3+ years of experience in a GMP environment.

Responsibilities

• Manage qualification, operation, maintenance, improvement, and decommissioning of QC instrumentation.
• Ensure QC instruments comply with regulatory guidelines and data integrity expectations.
• Develop and review SOPs, technical reports, user requirements, and specifications.
• Lead data integrity initiatives and periodic instrument reviews.
• Recommend user roles and privileges; design instrument operating instructions and PM plans.
• Oversee CAPAs and corrective actions for analytical instruments.
• Collaborate with stakeholders and cross-functional partners to ensure compliant operations.

Skills

Data integrity

Regulatory compliance

SOP development

CAPA / deviation handling

Cross-functional collaboration

Vendor management

Problem solving

Communication

Education

Bachelor’s in Chemistry/Biochemistry/Biological Sciences/Engineering or related science

Master’s in Chemistry/Biochemistry/Biological Sciences/Engineering or related science

PhD in Chemistry/Biochemistry/Biological Sciences/Engineering or related science

Tools

UPLC/HPLC

iCIEF

Gel Electrophoresis/Western Blot

Plate Readers

qPCR

Spectrophotometry

Mass Spectrometry

Job description

FUJIFILM Holdings America Corporation in North Carolina is seeking a Sr. Specialist 2, QC Instrumentation to own the lifecycle of analytical instruments in a high‑impact quality control team.

You will lead qualification, routine operation, maintenance, continuous improvement, and decommissioning with minimal supervision while ensuring data integrity and regulatory compliance. You will partner with cross‑functional teams and external vendors to solve complex problems, drive improvements, and