QC Analyst, Cell Therapy (3rd shift)
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 QC Analyst performs Quality Control assays for in-process control and release of cell therapy products and Stability Studies. Maintain data and follow cGMP regulations including writing deviations and other Quality documentation. Skill set includes (but is not limited to) working knowledge of Immunofluoresence, Basic Cell Culture, Sample Handling and Flow Cytometry.
Please note this shift is 3rd/Flex shift opening. You will be paid for 3rd shift while flexing to work 1st shift.
Please ensure you can work this schedule prior to applying:
· 3rd shift schedule is 10pm – 8am, Sunday-Thursday
*Please note 3rd shift has some flex opportunity to work 1shift. Please expect to work 3rd shift at least 60-70% and 1st shift 30-40% of the time.
- 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, cell counts (manual and automated), and immunoflourescence microscopy/spectroscopy assays.
- 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 of analytical methods including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation protocols.
- May initiate 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
- Bachelors degree in Sciences required
- Demonstrated knowledge in biological, cell based assays including flow cytometry.
- Should possesses knowledge of how to execute methods/procedures and operate equipment.
- Should perform tasks with strict adherence to cGMP and cGDP principles.
- Attains a solid understanding of cGMP principles.
- Acquires and documents training on all laboratory general tasks and is capable of performing assigned test methods and using associated instrumentation.
- Understanding of basic laboratory equipment and aseptic technique a plus.
- Proficient in the use of spreadsheets, databases, and word processing software.
- Problem solves by selecting appropriate alternative from defined options.
- Work is prioritized by supervisor.
- Timelines for completion of assigned tasks are determined by supervisor.
- Writing is typically free of punctuation, spelling and grammatical errors
- Records test results and maintains raw data and accurate laboratory records.
- Dependable and able to work well within a team.
- Interested in learning new things. Open to change.
- Is optimistic and displays a positive attitude even during periods of adversity.
- Shows initiative; takes action without being given instruction.
- Is able to lift the mood of those around him/her with his/her positive orientation
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.
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.