QC Compendial Testing Analyst I – GMP Focus

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks an Analyst I, QC Compendial Testing to ensure GMP-compliant operations per USP/EP/JP. You will support material life cycle management, contribute to technology transfer, and perform testing with established analytical methods to disposition materials.

The role emphasizes problem solving, attention to detail, and effective communication in a fast-paced laboratory setting.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or related scientific discipline with 0-1 years of applicable industry experience.
• Master’s degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0+ years of experience.
• Familiar with compendial testing methodology as it pertains to cGMP.
• Experience in assay troubleshooting and problem solving.
• Experience in a GMP environment.

Responsibilities

• Supports material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.) under supervision.
• Supports QC Compendial Testing team on internal TT meetings related to new products.
• Assists the QC Manager in the implementation of new technologies.
• Authors and reviews procedures, protocols, reports and specifications related to compendial testing of materials under supervision and support.
• Performs testing and disposition of incoming raw materials and components according to specifications and procedures; adheres to predefined turnaround times.
• Executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
• Initiates and implements TrackWise deviations and invalid assays, corrective and preventative actions (CAPAs); executes lab exceptions.
• Performs routine investigations in support of Out-of-Specification testing results.
• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.
• Follows established policies and procedures and escalates to management areas where enhancements will improve daily work.
• Reviews new and updated specifications.
• Utilizes Material Safety Data Sheets to properly assess chemical hazards, spill response procedures, and PPE requirements, if indicated.
• Performs other duties, as assigned.

Skills

Computer proficiency

Problem solving

Interpersonal skills

Fast-paced work

Attention to detail

Verbal and written communication

Independent work

Team collaboration

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry or related scientific discipline

Master’s degree in Biology, Chemistry Biochemistry, Microbiology or related field

Tools

TrackWise

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks an Analyst I, QC Compendial Testing to ensure GMP-compliant operations per USP/EP/JP. You will support material life cycle management, contribute to technology transfer, and perform testing with established analytical methods to disposition materials.

The role emphasizes problem solving, attention to detail, and effective communication in a fast-paced laboratory setting.