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QA Principal Operations Specialist 2 at US02 Lonza Biologics Inc.

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Portsmouth, New Hampshire





Job Description:

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 

Do you want to help us as we shape the future of this great organization?

 

Job Description Summary

The Cell Therapy Operations Specialist II is a strong partner with the Cell Therapy Operations group, customers, and the site Quality Assurance group.

Key Responsibilities:


  • On-the-floor QA support

  • Batch record review

  • Deviation review and approval,

  • Change control

  • Review of procedures and Master Batch Records.  

Minimum Educational/Experience Requirements:


  • Intermediate to advanced years in cell therapy and/or aseptic processing

  • Bachelors Degree in Sciences or related field

  •  A strong foundation in application of GMPs in a drug substance or drug product manufacturing environment is critical, as is an ability to quickly assess respond to site needs.

  • Must be able to appropriately apply GMPs for biologics, drugs and medical HCTP to situations for which precedents have not been set.

  • Prior experience in cell therapy and/or aseptic processing is desired, but not essential. 

 

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.

 

Lonza.  The place to Go, Stay and Grow.