Stability 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 (Quality Control ) Stability Analyst  supports the Stability department by performing biochemistry, chemical, and physical analysis for bulk drug substance, drug product, and special project samples. Helps junior analysts to do the same. In addition, the senior analyst supports the Stability department by generating, reviewing, approving and owning quality records such as local documents, deviations, CAPAs and change records.

Key responsibilities:

  • Testing and analysis of Stability samples and special projects.
  • Review of analytical results and completion of release functions in LIMS or other computerized systems
  • Train and mentor junior analysts
  • 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
  • Support and lead projects – such as method transfers, new instruments, method qualifications
  • Support and potentially lead continuous improvement projects in the Stability Laboratory such as 5S, 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
  • May be required to generate, execute, and summarize special laboratory studies
  • Ensure personal training requirements are met and that training records are current
  • Perform other duties as assigned.

Key requirements:

  • Bachelors  -  Life Science  
  • Advanced Experience - Manufacturing - pharmaceutical
  • Excellent written and verbal communication skills.
  • Embraces a culture of sharing knowledge and training others.
  • Strong ability to Analytical, prioritization, problem solving, and decision making skills
  • Experience with GMP Quality Systems such as TrackWise, LIMS
  • Demonstrated working knowledge of assays/equipment in functional area.
  • Computer literate and competent with a working knowledge of word processing and spreadsheets (such as Microsoft Office).
  • Must be detail-oriented, conscientious, and responsible.
  • Can demonstrate the ability to guide people, encourage teamwork, and teach assays.
  • Working knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs.

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: R37647