QC Compendial Testing Specialist — Material Transfers

Merck & Co.; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Scientist 1, QC Compendial Testing to support technology transfer of material methods and onboarding of new materials. You will assess testing requirements, participate in change controls, and perform release testing using established analytical methods.

The role emphasizes collaboration with cross-functional teams, maintaining data integrity, and ensuring compliance with cGMP and GDP standards while contributing to TT project timelines and

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry or related field with 5 years of industry experience; OR a Master’s degree with 3+ years; OR a PhD with no experience.
• Experience with compendial testing methodology as it pertains to cGMP.
• Experience with method transfers.
• Strong knowledge of GMP/GLP guidelines and cGMP compliance.

Responsibilities

• Serve as SME for designated methods transferred to Holly Springs site.
• Coordinate release, sampling and chemical analysis of materials and prepare monthly release metrics.
• Represent QC Compendial Testing in TT meetings related to new products.
• Execute change controls, vendor notifications and Trackwise deviations/CAPAs.
• Maintain laboratory systems, ensure data integrity and support audits/inspections.

Skills

Chemical knowledge

Data analysis

Analytical skills

Teamwork

Project management

Multi-tasking

GMP/GLP understanding

Communication skills

Education

Bachelor's degree in Chemistry or related field

Experience with compendial testing

Experience with method transfers

Advanced degree optional

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks a Scientist 1, QC Compendial Testing to support technology transfer of material methods and onboarding of new materials. You will assess testing requirements, participate in change controls, and perform release testing using established analytical methods.

The role emphasizes collaboration with cross-functional teams, maintaining data integrity, and ensuring compliance with cGMP and GDP standards while contributing to TT project timelines and