QC Senior Analyst

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.

The QC Senior Analyst (Chemistry, Biochemistry or Laboratory Technical Services) supports the Quality Control department by performing quality testing and review of in-process, final product, raw materials, on-going stability studies and special project samples. The senior analyst supports the Quality Control group by generating, reviewing, approving and owning quality records such as local documents, deviations, CAPAs and change records.

The QC Senior Analyst serves as the department’s SME in chemistry, biochemistry, microbiology or laboratory technical services (method transfer, validation, qualification, etc.). In addition, this role serves as a mentor and trainer for junior personnel.

Key responsibilities:

  • Testing and analysis of in-process, lot release, raw materials and stability samples
  • Review of analytical results and completion of release functions in LIMS or other computerized systems
  • Create and own quality records, i.e. deviations, CAPAs, change control records
  • Perform deviation investigations and write lab investigation reports
  • Create, revise and review quality GMP documents, i.e. local SOPs and assay worksheets
  • Leads projects – such as method transfers, new instruments, method qualifications
  • Leads continuous improvement projects in the QC Laboratories such as 6S, Kaizen, Just-do-it's, and VIP
  • Perform equipment maintenance and calibrations as required.
  • Support execution of validations for lab equipment, lab methods, or facility projects
  • Generate, execute, and summarize special laboratory studies
  • Ensure personal training requirements are met and that training records are current.

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: R37537