QC Compendial Testing Analyst I — GMP Method Transfer

FUJIFILM; Holly Springs (NC); On-site; USD 52,000 - 72,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks an Analyst 1 for QC Compendial Testing to support GMP-compliant materials testing and TT activities. You will assist in establishing specifications, perform material testing, and help manage deviations and CAPAs under supervision.

The role emphasizes cross-functional collaboration, adherence to SOPs, and thorough documentation in a fast-paced biopharma QC environment.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or related scientific discipline with 0-1 years of applicable industry experience.
• Basic understanding of GMP, GLP, GDP requirements.
• Master’s degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0+ years of experience.
• 1-3 years relevant 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

Attention to detail

Communication skills

Independent with supervision

Fast-paced environment

Education

Bachelor’s degree in Chemistry/Biology/Microbiology/Biochemistry or related

Master’s degree in Biology/Chemistry/Biochemistry/Microbiology or related

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks an Analyst 1 for QC Compendial Testing to support GMP-compliant materials testing and TT activities. You will assist in establishing specifications, perform material testing, and help manage deviations and CAPAs under supervision.

The role emphasizes cross-functional collaboration, adherence to SOPs, and thorough documentation in a fast-paced biopharma QC environment.