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Quality Control Scientist 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 Quality Control Scientist acts as a team member of the Quality Control department to support technology transfer, validation, deviation support, and investigation projects. Subject Matter Expert for all disciplines. Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables. Supports the review of all regulatory documents including APRs and BLAs. Direct contact with customers and project teams. Acts as advisor to junior staff to meet schedules and/or resolve technical problems. Troubleshoot assay and instrumentation issues involving data mining, trending and analysis to identify problems. Provides hands-on and theoretical training as appropriate for QC and other operational groups

Key Accountabilities and Duties:


  • Oversee assigned projects in group and ensure on track for on-time completion

  • Represent QC and Lonza in customer meetings to receive/deliver information, request and requirements.

  • Document writing/review for transfers/validations/investigations

  • Measures throughput, performance and other appropriate metrics and report them to management

  • Other – such as leading OE initiatives and improvements.

  • Perform other duties as assigned

Minimum Required Qualifications/Skills:


  • Bachelor degree and/or Advanced Graduate degree (MS/PhD)

  • Preferred area of study: Microbiology, Biochemistry or equivalent Science Field

  • Experience in a GMP/Professional environment

  • Use of Microsoft Suites (Word, Excel, Powerpoint)

  • Expert in all applicable laboratory software and hardware systems

  • Demonstrated expertise and proficiency in method transfer and method validation

  • Use of GMP Quality Systems such as: TrackWise, LIMS

  • Experience with Raw Material transfers preferred

  • Able to communicate in both written and verbal format

  • Able to speak publicly

  • Makes quality decisions independently

  • Method development  highly preferred

 

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.