Job Description

QA Specialist at public.client.lonza.display.name summary:

The QA Specialist at Lonza is responsible for conducting quality control testing for in-process and final product drug lots, ensuring high-quality results to meet manufacturing demands. This role requires a strong understanding of quality systems and the ability to recognize deviations from accepted practices while working in a cGMP environment. Candidates must hold a degree in a related science field and possess 2-4 years of industry experience, with proficiency in Microsoft Office and laboratory computer systems.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Check out this video about what a career at our Portsmouth NH facility could look like for you: Your Career with Lonza in Portsmouth, NH (youtube.com)

Job Summary

The Quality Control (QC) Analyst will act as a team member of the Quality Control department to support production of in-process and final product drug lots for customers. They will also participate in quality testing for ongoing customer stability studies and provide on-time, high quality results to meet Lonza’s manufacturing demands. A QC Analyst applies job skills and company policies and procedures to complete a variety of tasks. They will work on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required and works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.

10 Hour Night Shifts Either:

Sunday - Wednesday: 8:00 pm to 6:30 am or

Wednesday - Saturday: 8:00 pm to 6:30 am

Key Responsibilities

• Running test samples for in-process, lot release and stability studies.

• Reviewing assays.

• Writing quality records (Deviations, CAPA, Change Control) and test methods.

• Performs other duties as assigned.

Key Requirements

• Bachelor's or Associate's Degree preferably in Microbiology, Biochemistry, or related science discipline.

• 2-4 years industry experience preferably in a cGMP environment.

• Use of Microsoft Suites (Word, Excel, PowerPoint).

• Use of Laboratory computer systems.

• Experience using GMP Quality Systems such as: TrackWise, LIMS preferred.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Keywords:

Quality Assurance, Quality Control, cGMP, Biochemistry, Microbiology, Laboratory Testing, Drug Manufacturing, Stability Studies, Deviation Management, Pharmaceutical

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