QC Release Testing Analyst

United States, Walkersville (Maryland)

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.

The QC Release Testing Analyst is responsible for executing all aspects of release testing of raw materials, intermediates and finished goods to include sterility, bioburden, growth promotion qualification, routine cell, chemistry, biochemistry and endotoxin detection testing according to Standard Operating Procedures and Test Methods in compliance with cGMP/GLP while working in a team atmosphere. 

Key Responsibilities:

  • Performs all aspects of sterility testing.  This includes, but is not limited to, preparation and distribution of samples, environmental monitoring, core cleaning, bioburden, growth promotion qualification, and record management for all sterility testing.
  • Performs routine cell based testing, chemistry, biochemistry, and endotoxin detection testing of raw materials, intermediates and finished products according to Standard Operating Procedures and Test Methods in compliance with cGMP/GLP and USP guidelines utilizing proper aseptic techniques (where applicable)
  • Run analytical method transfer and qualification/validation experiments per approved protocols and with detailed instruction. Record, analyze, and review all data related to testing.
  • Perform general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies; Maintain compliance with all required training
  • Performs project related tasks as assigned with detailed instruction. May write and revise Standard Operating Procedures. May train other lab analysts on routine test methods. Assists with OOS/deviation investigations.
  • Perform other duties as assigned. 

Key Requirements:

  • Bachelor’s degree in a scientific discipline (or equivalent experience) and laboratory experience or vocational educational experience in a field like chemistry or biology
  • Preferred area of study:  Biology, Chemistry, Biochemistry with experience in a GMP/GLP related environment
  • Displays solid understanding of the process and workflow of daily job activities as it pertains to equipment and methods
  • Demonstrated dependability, initiative and the ability to work well within a team
  • Able to work with limited supervision on routine work or basic troubleshooting. Follows supervisory instructions as requested; communicating issues effectively and in a timely manner

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: R25379