Analyst 2, QC
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.
The role is responsible for conduct test and scheduling/ coordinating of testing with other departments to ensure timely delivery of results. Role is required to perform peer review of laboratory data, support OOS and Deviation investigations. The selected candidate should possess a good understanding and execution of spectroscopy, and other assigned methods which may include chromatography methods (HPLC), ELISA, PCR, CE, SDS-PAGE, IEF, icIEF, TOC, Protein concentration, osmolality, potency methods, appearance and other physiochemical methods.
- To prioritize and perform the various testing/analysis in timely manner, in order to support the business requirements.
- Analysis of final product, in-process samples according to Standard Operating Procedures and Test Methods.
- Documentation and review of results in accordance with current Good Manufacturing Practices (cGMP).
- Problem solving of analytical methods as well as troubleshooting of equipment.
- Involvement in method transfers and validation.
- Involved in equipment qualification, maintenance and troubleshooting,
- Prepare, maintain standards and reagents as required by GMP documents.
- Assay trend analysis, document revision and update.
- General lab support including housekeeping, equipment maintenance, inventory of supplies, lab supplies ordering, management of glass wares, autoclaving etc.
- Support sample logistics area including retention sample storage, external lab test, QC documents control, shipment of QC samples.
- Support / Perform OOS, deviation investigations. Draft investigations reports.
- Author Change Controls, Test Methods, SOPs.
- Responsible to follow data integrity requirements.
- Any other duties as assigned by your Supervisor/Manager.
- Degree in a relevant Science field or Equivalent.
- Relevant years of Lab related experience in a biotech or medically related field.
- Understand the principle and execution of ELISA, qPCR, potency, CE-SDS and iCIEF methods (preferably).
- Knowledge and Power User of Empower 3 (preferably).
- Relevant experience and accomplishment to dictate final position for which the candidate may qualify.
- Knowledge in cGMP regulations.
- Good problem solving and analytical skills.
- Good communication 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 achieve 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.