QC Analyst II - Micro

United States, Hayward (California)

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.

QC Analyst II – Micro is responsible for performing biological, chemical and physical analyses on pharmaceutical products and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs.

Key Accountabilities:

  • Conduct biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility.  Work under some supervision.
  • Testing as required supporting microbial identifications, bioburden analysis, biological indicators, growth promotion, water, and endotoxin.  Will be required to read microbial plates and interpret test results.  Some troubleshooting will be required.
  • Support and potentially lead continuous improvement projects in the QM Laboratories such as 5S and Kaizen.
  • Serve as Mentor to Quality Control Analyst (QCA) I positions. Provide training and work direction for QCA I positions as required.
  • Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data.
  • Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete all testing, including special project / protocol testing in a timely and appropriate manner.
  • Pickup, receive, aliquot and distribute samples to the appropriate laboratory.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Investigate deviations, write events, and lab investigation reports

 Key Requirements:

  • High School Diploma or Equivalent Experience
  • Preferred Area of Study- Science Related Discipline
  • Entry to Intermediate levels of experience, in a manufacturing setting preferred.
  •  Biopharmaceutical/process experience preferred, but not required at this level
  • Proven logic and decision making abilities, critical thinking skills.
  • Strong written and communication skills required.
  • A good understanding of design principles and standards within Bio-pharmaceutical facilities.

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: R48649