QC Specialist

United States, Portsmouth (New Hampshire)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

Quality Control Technical Services (QCTS) Specialists perform tasks to support investigations, reports and method transfer activities of the QC Scientists.  These tasks include statistical data analysis, report writing and review, purchasing materials and instruments, supporting IQ/OQ/PQ ( Installation Qualification/Operational Qualification/Performance Qualification) of instruments, process improvement, running assays and training analysts as needed.  Applies job skills and company's policies and procedures to complete a wide range of difficult tasks. Works on assignments that are non-routine where judgment is required in resolving problems and making routine recommendations. Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. 

Key responsibilities:

  • Managing data and analysis of data to support OOT (out-of-turn), OOC ( out-of-control) reports and additional reports
  • Supporting instrument IQ/OQ/PQ, purchase and training
  • Lead Process Improvement initiatives for Technical Transfers, Reports and investigations
  • Support and/or drive QCTS Change Controls and CAPA (Corrective and Preventative Actions) activities
  • Independently drive projects to on-time completion
  • Perform other duties as assigned. 

Key Requirements:

  • Bachelor’s degree or relevant experience preferred     
  • Sufficient experience in a cGMP environment, preferably a quality control laboratory
  • Experience with Microsoft programs such as Excel, Word and PowerPoint
  • Working experience with LIMS, Trackwise, Statistica or other statistical platform.
  • Working experience with Statistical Process Control
  • Strong communication, technical writing, and interpersonal skills
  • Strong organizational and time management skills
  • Exercises judgment within defined practices and policies in selecting methods and techniques for obtaining solutions and/or taking appropriate action. 
  • Self-motivated team player
  • Prioritizes and makes good use of time
  • Ability to train and teach on basic procedures; demonstrates appropriate procedures, a careful listener and fosters learning of those being trained.

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 it is 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: R21726