QC Senior Lead Analyst

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. 

Lonza in Portsmouth, NH is searching for an experienced QC Sr Lead Analyst to join our QC team. As our QC Sr Lead Analyst, you will coordinate the teams work for the shift and be a team member of the Quality Control department to support production. You will also participate in quality testing for ongoing customer stability studies and provide on time, high quality results to meet Manufacturing demands. This role works Monday – Friday 8:30 p.m. – 5 a.m.

Key responsibilities: 

  • Execution and review of test samples for In-Process, Lot Release and Stability studies.
  • Participates in execution and review of assays for method transfers, validations, and investigations.
  • Performing technical writings (deviations, change controls, CAPA, Quality Tag Outs).
  • Scheduling nightly workload for the team both short term and long term, as needed.
  • Provide guidance to junior staff or other departments to achieve goals in accordance with established policies.

Key requirements: 

  • Bachelor or Associates Degree. Preferred area of study in Microbiology, Biochemistry or Related Science Fields.
  • Experience with leading a team.
  • Significant experience within cGMP industry.
  • Significant experience with HPLC, UPLC and spectroscopy.
  • Significant experience with equipment troubleshooting.
  • Working knowledge with Trackwise for deviation writing, OOS investigation and change controls.
  • Previous experience using GMP Quality Systems (ex. TrackWise, LIMS).
  • Excellent ability to speak publicly. Able to maintain control of meetings as required. Holds group meetings as backup to Supervisor, delivering clear concise messages.
  • Excellent ability to interpret data. Makes more advanced quality decisions independently and understands when to escalate quality concerns to management.

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. 

Reference: R26558