Senior QC Analyst – Compendial Testing & Tech Transfer

FUJIFILM Healthcare Americas Corporation; Holly Springs (NC); On-site; USD 65,000 - 95,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Analyst 1 for QC Compendial Testing to ensure GMP-compliant operations per USP/EP/JP standards. You will participate in technology transfer of analytical methods into QC labs and perform material testing with established methods.

The role collaborates with QA, supply chain, and manufacturing to resolve quality issues and support timelines, with growth opportunities in technology implementation.

Qualifications

• Excellent oral and written communication in English required.
• Strong analytical skills with data interpretation.
• Ability to work cross-functionally with QA, Supply Chain, Manufacturing and Contract Labs.
• Familiarity with compendial testing methods (USP/EP/JP) and cGMP.

Responsibilities

• Supports material lifecycle management including new material assessment and specification maintenance.
• Authors and reviews procedures, protocols, reports and specifications for materials requiring compendial testing.
• Performs routine and non-routine testing of incoming materials per compendial methods and internal SOPs.
• Handles change controls and vendor change notifications; initiates CAPAs and lab deviations.
• Ensures adherence to quality policies, SOPs, and maintains integrity of lab results and safety.

Skills

Communication skills

Fluency in English

Analytical skills

Team collaboration

Safety procedures

Education

Bachelor's degree in Chemistry/ Biology / Microbiology / Biochemistry

Master's degree in Chemistry/ Biology / Biochemistry or related field

Tools

Trackwise

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Analyst 1 for QC Compendial Testing to ensure GMP-compliant operations per USP/EP/JP standards. You will participate in technology transfer of analytical methods into QC labs and perform material testing with established methods.

The role collaborates with QA, supply chain, and manufacturing to resolve quality issues and support timelines, with growth opportunities in technology implementation.