QC Analyst III, Release Testing

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 performs routine and specialized cell, chemistry, biochemistry, and microbiological based testing of raw materials, intermediates and finished products according to Standard Operating Procedures and Test Methods in compliance with cGMP/GLP while working in a team atmosphere. Individual is responsible for maintaining accurate data/records.

Key responsibilities:

  • Performs Sterility Testing per USP <71> for raw materials, intermediates and finished products according to Standard Operating Procedures and Test Methods, in compliance with cGMP and utilizing proper aseptic techniques.
  • Performs all aspects of Bioburden Testing, Mycoplasma Testing, Growth Promotion Qualification (GPQ) Testing for raw materials and Aseptic Process Simulation (APS) support according to Standard Operating Procedures and Test Methods, in compliance with cGMP and utilizing proper aseptic techniques
  • Performs routine and specialized 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); Performs routine utility system sampling.
  • Writes and revises Standard Operating Procedures and provides suggestions for method improvements.
  • Provides support to both QC and interdepartmental projects.  May serve as QC representative on project teams.
  • Trains other analysts on basic and specialized activities.
  • Participates in /performs OOS/Deviation Investigations
  • Runs analytical method transfer and qualification/validation experiments per approved protocols with minimal guidance. Records, analyzes, and reviews all data related to testing.
  • Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies; Maintains compliance with all required training.

Key requirements:

  • In-depth knowledge of cGMP principles.  Able to identify breach of cGMP principles and provide suggested corrective actions.
  • Acquires and documents training on all laboratory general tasks and is capable of performing assigned test methods and using associated instrumentation.
  • Demonstrates understanding of routine laboratory testing and principles behind methodology.
  • Is developing Subject Matter Expertise and is recognized as a source of reliable information by less experienced analysts.
  • Understands basic laboratory equipment and aseptic technique.
  • Completes assignments on-time and accurately.
  • Displays self-confidence and ability to work independently.
  • Shows initiative; takes action without being given instructions.
  • Communicates verbally and in writing in a clear and concise manner; writing is typically free of punctuation, spelling and grammatical errors.
  • Is able to effectively present information and ideas formally and informally to others in a manner that facilitates understanding.

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: R20615