Quality Control Analyst - Cell Therapy

United States, Hayward (California)
United States, Houston (Texas)

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 Quality Control Analyst performs 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.

This is a first shift position working Monday thru Friday 8-5pm with some nights and weekends per project needs.

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. 

Key requirements:

  • Bachelors degree in Sciences required
  • Experienced knowledge working in scientific laboratory
  • Experienced knowledge working in cGMP environment
  • Demonstrated knowledge in biological, cell based assays including flow cytometry
  • Should possess knowledge of how to execute methods/procedures and operate equipment
  • Should perform tasks with strict adherence to cGMP and cGDP principles
  • Knowledge of basic and specialized lab equipment
  • Able to identify breach of cGMP principles and provide suggested corrective actions
  • Is developing Subject Matter Expertise and is recognized as a source of reliable information by less experienced analysts
  • 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
  • Records test results and maintains raw data and accurate laboratory records
  • Is able to effectively present information and ideas formally and informally to others in a manner that facilitates understanding
  • Provides suggestions for improvement to documentation and workflows
  • Dependable and able to work well within a team
  • Supports development of others through mentoring and training 
  • Interested in learning new things
  • 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.

Reference: R40950
Similar Jobs