Senior QC Microbial Analyst - In-Process & Stability

Katalyst CRO; Portsmouth (NH); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Quality Microbial Control Analyst V to join our team. The role supports production of in-process and final product drug lots, participates in stability testing, and ensures timely, high-quality results aligned with manufacturing demands.

The ideal candidate will apply GMP knowledge, perform method transfers and CAPA-related tasks, and act as a subject-matter expert across the department. This on-site role emphasizes data integrity and quality record writing.

Qualifications

• Bachelors in Microbiology, Biochemistry, or related field.
• 510 years of relevant QC Micro experience in GMP.

Responsibilities

• Applies job skills and company's policies and procedures to complete a variety of tasks.
• Running test samples for In-Process, Lot Release and Stability studies.
• Support Utility and HVAC monitoring and sampling throughout the facility
• Reviewing assays.
• Training others.
• Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods.
• Projects such as method transfers, new instruments, method qualifications.
• Use of Microsoft Suites (Word, Excel, PowerPoint).
• Use of Laboratory computer systems.
• Potential previous use of GMP Quality Systems such as: TrackWise, LIMS.
• Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures.
• Perform other duties as assigned.
• Back-up to Supervisor Independently making quality decisions with input

Education

Bachelor's degree in Microbiology, Biochemistry, or related field

Tools

TrackWise

LIMS

Microsoft Office (Word, Excel, PowerPoint)

Job description

Katalyst CRO is seeking a Quality Microbial Control Analyst V to join our team. The role supports production of in-process and final product drug lots, participates in stability testing, and ensures timely, high-quality results aligned with manufacturing demands.

The ideal candidate will apply GMP knowledge, perform method transfers and CAPA-related tasks, and act as a subject-matter expert across the department. This on-site role emphasizes data integrity and quality record writing.