QC Analyst- Sterility Testing

United States, Portsmouth (New Hampshire)

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 QC Analyst will act as a team member of the Quality Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies. Provide on-time, high quality results to meet Manufacturing demands.

A QC Analyst: Applies job skills and company's policies and procedures to complete a variety of tasks of increase scope.  May be assigned to work on special projects and maintain the team schedule. Also may provide support to others. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.

*This position has a schedule of M-F business hours*

Key Responsibilities: 

  • Support product and APS sterility testing and validation.
  • Running test samples and performing EM and utility sampling for In-Process, Lot Release, validation, and manufacturing activities.
  • Reviewing QC data and ensuring OTIF for lot-release deliverables.
  • Help maintain the weekly EM schedule.
  • Training other analysts and manufacturing operators.
  • Writing – Quality Records (Deviations,  Quality Events, Test Methods, Trending Reports, EM Memos, SOPs).
  • Ability to think critically and make quality decisions with input. Recognize and avoid potential deviation or compliance risks.
  • Special projects – such as method qualifications and instrument validations.
  • Level of this role is dependent on applicant's experience

Key Requirements: 

  • Associate Degree, or Bachelor Degree preferred, area of study in Microbiology, Biochemistry or Related Science Fields.
  • Intermediate experience within industry in a quality control GMP manufacturing/laboratory setting. 
  • Previous experience using GMP Quality Systems (ex. TrackWise, LIMS, iLab, and MODA) preferred.
  • Excellent communication skills with the ability to collaborate across multiple teams and projects.
  • Ability to bend, crouch, and lift arms over head.
  • Ability to multi-task and prioritize responsibilities.

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: R44599