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Quality Control Analyst - Cell Therapy at US05 Lonza Houston Inc.

Posted in Science 30+ days ago.

Type: Full-Time
Location: Houston, Texas





Job Description:

 

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, Cell Therapy performs Quality Control assays for product release of cell therapy products, Raw Material Release 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, Sample Handling and Flow Cytometry.

This is a first shift position working four-10 hour days Sunday thru Wednesday 8am-6pm

Key responsibilities:


  • Performs Quality Control (QC) biological/cell based testing of Cell Therapy 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.

  • 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.

  • Performs general lab and equipment maintenance duties.

  • Performs other duties as assigned

Key requirements:


  • Bachelors degree in Sciences required

  • Working knowledge working in scientific laboratory

  • Working knowledge working in cGMP environment

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

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

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

  • Demonstrates a solid understanding of cGMP principles.  Able to identify breach of cGMP principles

  • Demonstrated understanding of routine laboratory testing and principles behind methodology.

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

  • Exercises judgment based on practice and precedence. 

  • Able to prioritize work with input from supervisor.  Makes good use of time.

  • Works together with supervisor to identify timelines for assigned tasks.

  • Communicates verbally and in writing in a clear and concise manner.

  • Records test results and maintains raw data and accurate laboratory records.  Able to identify documentation errors routinely via self check.

  • Demonstrated understanding and consideration of others.  Supportive of others' attempts at improvement.

  • Able to work with minimal supervision on routine tasks.  Completes assignments on-time.

  • Is willing to turn ideas into action – to make things happen.  Does not procrastinate. 

  • Is optimistic and displays a positive attitude even during periods of adversity. Has a ‘can-do’ attitude and is solution focused.

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. 





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