Quality Control Analyst II

United States, Hayward (California)

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.

Quality Control Analyst II will conduct 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 responsibilities:

  • 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.
  • Support and potentially lead continuous improvement projects in the QC Laboratories such as 5S, Kaizen, Just-do-it's, and VIP.
  • 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.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Investigate deviations and write nonconformance and lab investigation reports.
  • Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
  • Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.

Key Requirements:

  • Bachelor’s Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with intermediate experience, or Master’s Degree in Chemistry, or Biological Sciences, with advanced years of Experience
  • Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
  • May be required to work or be assigned to a different shift to meet business needs.  Must be willing to work off shift hours.
  • Must be able to work supplemental hours as necessary to complete work commitments.
  • Primarily inside working conditions

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility.  How we achieve our business results is just as important as the achievement 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: R24026