Senior QC Lead – Raw Materials (GMP/USP)

FUJIFILM Holdings America Corporation; North Carolina; On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical benefits

401(k) Plan

Paid vacation

Job summary

FUJIFILM Biotechnologies in North Carolina is seeking a Lead QC Associate II – Raw Materials to lead testing and release of incoming raw materials under GMP-compliant workflows.

You will drive CAPA, investigations, data integrity, and continuous improvement in the QC laboratory, collaborating with cross-functional teams to ensure materials meet specs for manufacturing. This on-site role emphasizes lean methods and Six Sigma in a biopharma setting.

Qualifications

• BS/BA in science required with direct experience in QC/analytical labs.
• Experience with GMP/QA procedures and regulatory guidelines preferred.
• Knowledge of compendial methods and laboratory compliance expected.
• Experience with data integrity and technical writing is a plus.

Responsibilities

• Lead laboratory support functions in QC for raw materials.
• Oversee CAPA actions, deviations, investigations, and method revisions.
• Lead method transfers, validations, and qualifications.
• Support data review, reporting, and documentation.
• Ensure compliance with GMP and USP/EP/JP guidelines.
• Identify process improvements and drive lean lab principles.

Skills

CAPA management

Method transfers

Data review

Problem solving

Documentation

Education

BS/BA in science

Tools

FTIR

RAMAN

Karl Fischer

Polarimeter

Refractometer

Job description

FUJIFILM Biotechnologies in North Carolina is seeking a Lead QC Associate II – Raw Materials to lead testing and release of incoming raw materials under GMP-compliant workflows.

You will drive CAPA, investigations, data integrity, and continuous improvement in the QC laboratory, collaborating with cross-functional teams to ensure materials meet specs for manufacturing. This on-site role emphasizes lean methods and Six Sigma in a biopharma setting.