Lead QC Associate II, Raw Materials (GMP/USP/EP/JP)

FUJIFILM Holdings America Corporation; Northern (KY); Hybrid; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) plan

Paid vacation and holidays

Job summary

FUJIFILM Biotechnologies is seeking a Lead QC Associate II – Raw Materials for the Bioprocess Innovation Center in Morrisville, NC. The role ensures incoming raw materials meet specifications per GMP/USP/EP/JP and supports data integrity, documentation, and continuous improvement in the QC lab.

The position emphasizes lead responsibility for method transfers, validations, and data-driven decision making, with a focus on quality and regulatory compliance. Shift: Mon–Fri, 8am–5pm.

Qualifications

• BS/BA in science, preferably chemistry, biochemistry or pharmaceutical sciences, with at least 2 years of direct experience.
• Experience with compendial analysis (USP/EP/JP), method validation/verification, and analytical instrumentation.
• Strong documentation, data integrity, and quality systems knowledge.

Responsibilities

• Lead QC activities for raw materials sampling, testing, and release under GMP and regulatory standards.
• Act as SME for CAPAs, deviations, lab investigations, and method revisions.
• Lead/assist with method transfers, validations, and qualifications.
• Support data reviews, report generation, and interpretation of results.
• Identify process improvements using lean and six sigma principles.

Skills

CAPA management

Lean lab

Six Sigma

Data interpretation

Problem solving

Education

BS/BA in science

Tools

FTIR

RAMAN

Karl Fischer

Polarimeter

Refractometer

Job description

FUJIFILM Biotechnologies is seeking a Lead QC Associate II – Raw Materials for the Bioprocess Innovation Center in Morrisville, NC. The role ensures incoming raw materials meet specifications per GMP/USP/EP/JP and supports data integrity, documentation, and continuous improvement in the QC lab.

The position emphasizes lead responsibility for method transfers, validations, and data-driven decision making, with a focus on quality and regulatory compliance. Shift: Mon–Fri, 8am–5pm.