Senior QC Microbial Control Analyst & Technical SME

Katalyst CRO; Portsmouth (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in Portsmouth, NH is seeking a Quality Microbial Control Analyst V to join the Quality Microbial Control department. The role supports in-process and final product lots, and participates in stability studies, delivering on-time, high-quality results to meet manufacturing demands.

You will apply your GMP knowledge and data integrity practices, perform method transfers, write quality records, and train others while acting as a subject-matter expert across the facility.

Qualifications

• Bachelor’s in Microbiology, Biochemistry, or related field.
• 5–10 years of QC Micro experience in GMP.

Responsibilities

• Running test samples for In-Process, Lot Release and Stability studies.
• Support Utility and HVAC monitoring and sampling throughout the facility
• Reviewing assays and quality records such as Deviations, CAPA and Change Control.
• Training others and performing method transfers and instrument qualifications.
• Apply Data Integrity principles in all work as per DI policies.

Skills

GMP compliance

QC microbiology

Data integrity

Microsoft Office

Lab instrumentation

Education

Bachelor's in Microbiology/Biochemistry or related

Tools

LIMS

TrackWise

Excel

PowerPoint

Job description

Katalyst CRO in Portsmouth, NH is seeking a Quality Microbial Control Analyst V to join the Quality Microbial Control department. The role supports in-process and final product lots, and participates in stability studies, delivering on-time, high-quality results to meet manufacturing demands.

You will apply your GMP knowledge and data integrity practices, perform method transfers, write quality records, and train others while acting as a subject-matter expert across the facility.