QC Analyst

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

Description

The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies. Provide on-time, high quality results to meet Manufacturing demands. Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. May be assigned to work on special projects. Also may provide support to others in the absence of the supervisor. 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. Acts as an area SME providing technical support within the department and throughout the facility.

Key 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

Requirements

• Bachelors in Microbiology, Biochemistry, or related field.
• 5-10 years of relevant QC Micro experience in GMP.