Quality Control Analyst II at Lonza Inc.

Posted in Science 30+ days ago.

Type: Full-Time
Location: Walkersville, Maryland





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 Quality Control (QC) Analyst II is a mid-level analyst responsible for performing routine Environmental Monitoring (EM) and utility sampling as well as routine and specialized testing of raw materials, in-process materials, finished goods and stability samples.  All activities are required to be done in compliance with Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).  The individual performs routine testing and project related tasks while being responsible for general lab support activities as directed by management. 

 

Key responsibilities: 


  • Performs testing and enumeration in accordance with written procedures for raw materials, packaging components, in-process products, finished products and stability samples as needed. 


  • Performs testing to support Aseptic Process Simulations (APS), method validations, method transfers, process and cleaning validations as needed. 


  • Reviews, analyzes, interprets, and reports data following GDP and ALCOA+ principles in a timely manner. 


  • Prepares sample shipments and submission paperwork for contract laboratory testing and communicates with contract laboratory as needed. 


  • Authors, reviews, and revises SOPs, trend reports, and microorganism assessments as needed. 


  • Assists in the development of training plans and curricula; trains other analysts as needed. 


  • Leads OOS/deviations/ investigations and implements CAPA plans with oversight as needed. 


  • Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies.   


  • Develop skills to troubleshoot and perform minor maintenance, calibration and repair of laboratory equipment and software. 


  • Participate in validation of methods, commensurate with experience. 


  • Performs other duties as assigned. 


Key requirements: 


  • Bachelor’s Degree in a life sciences field 


  • 5+ years’ experience in Quality 


  • CGMP experience required 


 

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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