QC Compendial Testing Scientist I — Transfer & Release

Socket.dev; Holly Springs (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Scientist 1, QC Compendial Testing to participate in technology transfer and onboarding of new materials within the QC lab. You will assess testing requirements and support change controls with vendor data.

The role requires strong chemistry knowledge, experience with compendial methods, Trackwise, and adherence to cGMP/GDP. You’ll coordinate release, sampling, and TT milestones with teams.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or related field with 5 years of experience.
• Master’s degree in Chemistry, Biology, Microbiology, Biochemistry or related field with 3+ years of experience; OR PhD with no experience.
• Experience with compendial testing methodology per cGMP.

Responsibilities

• Act as SME for designated methods transferred to Fujifilm Biotechnologies, Holly Springs.
• Coordinate release/sampling and chemical analysis of materials; prepare metrics.
• Represent QC Compendial Testing in TT meetings with internal/external teams.
• Execute change control actions and vendor change notifications.
• Approve deviations, CAPAs, and lab exceptions as needed.
• Maintain timelines and coordination for TT project milestones.

Skills

Technical chemistry

GMP/GLP knowledge

Data analysis

Teamwork

Project management

Multi-tasking

Communication skills

Education

Bachelor’s degree in science

Master’s degree in science

PhD in science

Tools

Trackwise

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Scientist 1, QC Compendial Testing to participate in technology transfer and onboarding of new materials within the QC lab. You will assess testing requirements and support change controls with vendor data.

The role requires strong chemistry knowledge, experience with compendial methods, Trackwise, and adherence to cGMP/GDP. You’ll coordinate release, sampling, and TT milestones with teams.