QA Operations Associate

United Kingdom, Slough

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

We have a great opportunity available for a QA Associate – Batch Review to join our QA Operations team, which is part of our Quality Assurance Department. This is a permanent position based out of our state-of-the-art Slough facility.

As a QA Associate – Batch Review you will be part of a team ensuring that quality is maintained at an appropriate level meeting customer and regulatory expectations and enabling the site to deliver to relevant targets.

Key Responsibilities:

•Auditing documentation generated during manufacturing processes and for ancillary areas of manufacturing, co-ordinating of review and any follow-up action or corrections of GMP documentation

•Auditing documentation generated from the Analytical Services, Purification Development and Quality Control departments

•Acting as a point of contact for general queries relating to quality and escalating as required

•Expand and utilise knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel

•Raw material release

•Ensure current GMP requirements for all areas are met

•Assist in preparation of area for inspection readiness

•Advising operators on best practices for document completion, review and follow up actions or escalate if required

 Key Requirements:

•BSc or equivalent in a biology related field

•Experience working within QA ideally in a manufacturing environment with good knowledge of GMP.

•Working experience with Biologics.

•Great attention to detail

•Demonstration of workload prioritisation skills, decision-making and scheduling skills

This role is working Tuesday to Saturday.

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.

Reference: R23096