QA Operations Specialist
We have a great opportunity available for a QA Operations Specialist 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 Operations Specialist – 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.
This role is working 6pm-6am based on a 4 days on and 4 days off rota.
•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
•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
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.