QC Analyst

Katalyst CRO; Portsmouth (NH); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO in Portsmouth, NH is looking for a Quality Microbial Control Analyst V to support production and quality testing for drug lots. The ideal candidate will have a Bachelor's in Microbiology or Biochemistry and 5-10 years of QC Micro experience in GMP environments. Responsibilities include running test samples, reviewing assays, training others, and compliance with data integrity policies. Strong skills in GMP Quality Systems and laboratory computer systems are essential.

Qualifications

• 5-10 years of relevant QC Micro experience in GMP.
• Ability to recognize deviation from accepted practice.
• Experience in training others.

Responsibilities

• Support production of in-process and final product drug lots.
• Participate in quality testing for customer stability studies.
• Independently make quality decisions as back-up to Supervisor.

Skills

GMP Quality Systems

Test sample running

Data Integrity principles

Reviewing assays

Microsoft Office Suite

Technical support

Education

Bachelors in Microbiology, Biochemistry, or related field

Tools

Laboratory computer systems

TrackWise

LIMS

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.