QA 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 are currently looking for an experienced Quality Assurance Associate to be join our Centre of Excellence for biopharmaceutical process development and small-scale GMP manufacturing in Slough, UK.

This role will be working Night shifts on a shift pattern of 4 days on and 4 days off, working 6pm-6am.

Key responsibilities:

  • Auditing documentation generated during manufacturing processes and for ancillary areas of manufacturing, co-ordinating of review and any follow-up actions/corrections of GMP documentation.
  • Auditing documentation generated during development and laboratory processes, including protocols, assays/raw data and validation reports.
  • 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. Vials auditing and releasing and Cell Banking documentation auditing.
  • Ensure current GMP requirements for all area are met. Assist in preparation of area for inspection readiness.
  • Advising operators on best practices for document completion review and follow up actions/ escalate if required.
  • Identify discrepancies and deviations and to distinguish appropriate classification and appropriate follow-up actions in areas where trained. Developing ability to interpret and apply GMP regulations consistently.
  • Assisting with the mentoring and training of other departments in QA skills and knowledge.
  • DMS document editor for document errors identified in QA.
  • Performs basic document reviews of SOP’s, batch records, test methods, and logbooks

What we need you to have:

  • BSc in Life Sciences
  • Industry experience within Quality Assurance in a GMP environment.
  • Ideally have previous expereince working night shifts.

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: R25130