QC Compendial Testing Analyst I — GMP/USP Focus

Merck & Co.; Holly Springs (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC is seeking an Analyst 1 for QC Compendial Testing to ensure GMP-compliant operations per USP/EP/JP. You will participate in technology transfer of methods into the NC Quality Control Laboratory and perform testing and disposition of materials using established analytical methods.

The role requires a Bachelor’s degree in a relevant science with 0-1 years of industry experience, with opportunities to advance to master’s-level qualifications and

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or related science with 0-1 years of industry experience.
• Basic understanding of GMP, GLP, GDP requirements.
• Master’s degree preferred in related field.
• Experience with compendial testing methodologies (cGMP) is a plus.
• Experience with assay troubleshooting and problem solving is a plus.

Responsibilities

• Support material life cycle management under supervision.
• Support QC Compendial Testing team in TT meetings for new products.
• Assist in implementing new technologies.
• Perform testing and disposition of incoming materials according to specs.
• Handle change controls and vendor change notifications.
• Initiate TrackWise deviations and CAPAs; manage lab exceptions.
• Support investigations in Out-of-Spec results.
• Maintain laboratory systems to ensure data integrity.
• Follow policies and escalate improvement opportunities.
• Review new and updated specifications.
• Use MSDS to assess hazards and PPE requirements.
• Perform other duties as assigned.

Skills

Computer Proficiency

Problem Solving

Attention to Detail

Communication Skills

Team Collaboration

Fast-Paced Environment

Independent Work

Self-Driven

Education

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

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

Tools

TrackWise

Job description

Fujifilm Biotechnologies in Holly Springs, NC is seeking an Analyst 1 for QC Compendial Testing to ensure GMP-compliant operations per USP/EP/JP. You will participate in technology transfer of methods into the NC Quality Control Laboratory and perform testing and disposition of materials using established analytical methods.

The role requires a Bachelor’s degree in a relevant science with 0-1 years of industry experience, with opportunities to advance to master’s-level qualifications and