Senior QC Test Analyst — Compendial (GMP)

Socket.dev; Holly Springs (NC); On-site; USD 85,000 - 100,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Senior Analyst 1, QC Compendial Testing to ensure GMP-compliant operations per USP/EP/JP. The role supports technology transfer of methods into QC Lab and performs material testing and disposition using established analytical methods.

The position involves cross-functional collaboration to resolve quality issues, maintain lab integrity, and support manufacturing timelines in a fast-paced GMP environment.

Qualifications

• Bachelor’s degree in Chemistry or related field with 2+ years industry experience.
• Experience with compendial testing (USP/EP/JP) and cGMP.
• Experience with Trackwise preferred.

Responsibilities

• Support material life cycle management (new material assessment, specification establishment, maintenance of specifications).
• Authors and reviews procedures, protocols, reports and specifications related to raw materials and materials requiring compendial testing.
• Performs routine testing of incoming materials and components following compendial (USP/EP/JP) and internal methods.
• Collaborates cross-functionally with QA, Supply Chain, Manufacturing to resolve quality issues and support manufacturing timelines.

Skills

Communication

Analytical skills

Team collaboration

Attention to detail

Education

Bachelor in Chemistry / related field

Master in Chemistry / related field

Tools

Trackwise

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Senior Analyst 1, QC Compendial Testing to ensure GMP-compliant operations per USP/EP/JP. The role supports technology transfer of methods into QC Lab and performs material testing and disposition using established analytical methods.

The position involves cross-functional collaboration to resolve quality issues, maintain lab integrity, and support manufacturing timelines in a fast-paced GMP environment.