QC Cell Therapy Analyst II (2nd Shift)

Quality Control Analyst II

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.

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 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 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. 

• Shift will be PM shift (7:30 PM - 7:30 AM)

Key requirements:

• Bachelor of Science in a related field and advanced level of relevant

• Demonstrated knowledge in biological, cell-based assays including flow cytometry.

• Should have knowledge of how to execute methods/procedures and operate equipment.  

• Should perform tasks with strict adherance to cGMP and cGDP principles.

• Knowledge of basic and specialized lab equipment.

• Proficient in the use of spreadsheets, databases, and word processing software.

• Prior experience with SAP and TrackWise a plus.

• Uses knowledge of defined SOPs & policies to make decisions. Reviews more complex decisions with supervisor and/or other departments.

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.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.