Senior QC Analyst: GMP Compendial Testing & Tech Transfer

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 75,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a Senior Analyst 1, QC Compendial Testing to ensure GMP-compliant laboratory operations under USP/EP/JP regulations. This role supports technology transfer of methods into QC lab and conducts material testing and disposition using established analytical methods.

The position requires a strong background in compendial testing, cGMP experience, and collaboration with QA, manufacturing, and supply chain teams.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or related field with 2+ years of industry experience.
• Master’s degree in a relevant science with no prior experience.
• Experience with compendial testing methodology per cGMP.

Responsibilities

• Supports material life cycle management (new material assessment, specification establishment, maintenance of specifications, etc.).
• Authors and reviews procedures, protocols, reports and specifications related to raw materials and materials requiring compendial testing.
• Performs routine and non-routine testing of incoming materials and components following compendial (USP/EP/JP) and internal methods.
• Assesses and executes actions related to change controls and vendor change notifications.
• Initiates and implements TrackWise deviations, corrective and preventive actions (CAPAs), lab exceptions and invalid assays.
• Ensures adherence to company quality policies, SOPs and industry regulations while maintaining laboratory integrity.
• Assists in implementing new technologies and collaborates cross-functionally with QA, Supply Chain, Manufacturing and contract labs.
• Performs routine investigations in support of Out-of-Specification testing results.
• Provides technical guidance and training to junior analysts.

Skills

Analytical testing

Data interpretation

Quality systems

Cross-functional collaboration

Scientific writing

English fluency

Education

Bachelor’s in Chemistry/Biology/biochemistry

Master’s in relevant science

Tools

LIMS TrackWise

MS Office

Job description

FUJIFILM Biotechnologies is seeking a Senior Analyst 1, QC Compendial Testing to ensure GMP-compliant laboratory operations under USP/EP/JP regulations. This role supports technology transfer of methods into QC lab and conducts material testing and disposition using established analytical methods.

The position requires a strong background in compendial testing, cGMP experience, and collaboration with QA, manufacturing, and supply chain teams.