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Quality Control Assay Transfer and Qualification Specialist at Lonza Inc.

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Houston, Texas





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

Responsible for transferring assays from PD Analytics to Quality Control. Steps include Test Record and Test Record Form writing and training analysts from the Lot Release and Analytics Group on transferred assays. Responsible for writing Assay Qualification Protocols and Reports. Responsible for performing assays associated with Assay Qualification. May function as SME on specific assays, assisting with difficult Laboratory Investigations as needed. May interact with clients in meetings specifically about Assay Tech Transfer and/or Qualification.

 

Job Description

Responsible for transferring assays from PD Analytics to Quality Control.  Tasks include performance of wet work for new assays, writing Test Records and Test Record Forms, and initiating Change Controls. Also includes training additional analysts from Lot Release Group on new assays. Responsible for writing Assay Qualification Protocols and Reports and leading the performance of qualification wet work in the laboratory.

Reports test results, maintains raw data, and accurate laboratory records in

accordance with applicable SOPs.

Responsibilities 

Responsible for transferring assays from PD Analytics to Quality Control. Tasks include performance of wet work for new assays, writing Test Records and Test Record Forms, and initiating Change Controls. Also includes training additional analysts from Lot Release Group on new assays. Responsible for writing Assay Qualification Protocols and Reports and leading the performance of qualification wet work in the laboratory. Reports test results, maintains raw data, and accurate laboratory records in accordance with applicable SOPs. Prepares new Part Number requests for reagents and equipment not already in Lonza systems for new assays. Assists with difficult Laboratory Investigations as required if SME is needed for troubleshooting.

Education

Bachelors: Biochemistry, Bachelors: Biology, Bachelors: Cell Biology

 

Work Experience

Quality (Intermediate)

Certifications

 

Skills

Math, Science and Good Documentation. Working knowledge on a variety of laboratory equipment.

 

Language(s)

English

 

 

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.