Senior QC Analyst – Compendial Testing & GMP Excellence

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Analyst 1, QC Compendial Testing to ensure GMP-compliant operations. You will participate in technology transfer, perform material testing, and disposition using USP/EP/JP methods.

The role emphasizes collaboration across QA, manufacturing, and contract labs, with a focus on change controls, CAPAs, and maintaining laboratory integrity in a fast-paced environment.

Qualifications

• Must understand compendial testing methodology per cGMP.
• Strong analytical data interpretation and result troubleshooting.
• Ability to work with QA, manufacturing, and external labs.

Responsibilities

• Support material lifecycle management and specifications for raw materials.
• Draft and review procedures, protocols, and specs for compendial testing.
• Perform routine and non-routine testing of materials per USP/EP/JP and internal methods.
• Address change controls and vendor notifications; drive CAPAs and lab exceptions.
• Support Trackwise deviations and ensure adherence to quality policies and SOPs.
• Collaborate with QA, Supply Chain, Manufacturing, and Contract Labs to meet timelines.
• Assist investigations for Out-of-Spec results and maintain lab safety.

Skills

GMP compliance

Analytical skills

Data analysis

Cross-functional collaboration

Attention to detail

Communication skills

Education

Bachelor’s degree in science

Master’s degree in science (no experience)

Tools

Trackwise

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Analyst 1, QC Compendial Testing to ensure GMP-compliant operations. You will participate in technology transfer, perform material testing, and disposition using USP/EP/JP methods.

The role emphasizes collaboration across QA, manufacturing, and contract labs, with a focus on change controls, CAPAs, and maintaining laboratory integrity in a fast-paced environment.