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.
Please note this opportunity is third shift with some flex to the 1shift. Please expect to work 3rd shift at least 60-70%. The schedule will a 4X10, starting on Sunday evening and work week will end Friday morning. Third shift hours are typically from 10PM to 8AM.
The Quality Control Analyst will perform quality control assays for in-process control and release of cell therapy products and stability studies. Maintains data and follows Good Manufacturing Practices (cGMP) regulations including writing deviations and other quality documentation. Skill set includes (but is not limited to) working knowledge of Basic Cell Culture and Flow Cytometry.
Key responsibilities:
- Performs Quality Control (QC) biological/cell based testing of Cell Therapy in-process, release, and stability samples. Typical test methods performed include flow cytometry based assays, but analyst may also perform proliferation, ELISA, and cell counts (manual and automated).
- Write original and revise current SOPs, forms and test records. Writes edits and approves deviations and Corrective and Preventative Action Reports (CAPAs) as required. Responsible for initiating change controls and completing necessary documentation.
- Actively participates in support of Cell Therapy technology transfer activities and validation/qualification of analytical methods including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation/qualification protocols.
- Initiates Out of Specification (OOS) and deviation investigations as needed to address non-conformances in the lab.
- Orders supplies and reagents.
- Performs general lab and equipment maintenance duties.
- Performs other duties as assigned.
Key requirements:
- Associate Degree in Scientific Discipline. Bachelor’s Degree or Advanced Degree is a plus.
- Advanced knowledge in biological, cell based assays including flow cytometry.
- Ability to perform tasks with strong adherence to cGMP and cGDP principles.
- Knowledge of how to execute methods/procedures and operate equipment.
- Proficient in the use of spreadsheets, databases, and word processing software.
- Prior experience with SAP and TrackWise a plus
- Records test results and maintains raw data and accurate laboratory records
- Dependable and able to work well within a team.
- Is optimistic and displays a positive attitude even during periods of adversity.
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.
