QC Data Review Supervisor
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.
The QC data review and investigation team's supervisor is responsible for the comprehensive review of documentation, analytical data (including third party contract laboratories), and protocols/reports generated within the quality control laboratory. The supervisor ensures the laboratory is following applicable regulatory and compliance procedures (GMP, good documentation practices, etc.), including Lonza's policies.
The QC data review and investigation supervisor is also responsible for leading, under the laboratory manager's guidance, laboratory investigations and deviations.
Manage/review the following laboratory documents, as assigned, to ensure that they are accurate and complete and that the work performed is compliant with applicable procedures and analytical methods:
- Data documented by laboratory personnel within laboratory notebooks, worksheets, and logbooks.
- Data generated by laboratory instrumentation group, both hard-copy reports, and electronic data/results.
- Completed laboratory logbooks (e.g., instrument use and maintenance logbooks).
- Accuracy and completeness of results transcribed to LIMS, MODA, data tables, specification/CofAs, protocols, and reports.
- Laboratory investigations and deviations.
- Method validation/verification protocols and reports, including Method Transfers and feasibility studies.
In addition, the supervisor performs and maintains
- KPIs related to data review such as documentation error, turnaround time, and leads improvement projects.
- Updates worksheets and laboratory procedures as needed
- Drives laboratory investigations and deviations and ensures on-time closure.
- Supports the testing teams by scheduling data review.
- Preferred prior experience in laboratory management (5 + years)
- Strong analytical and problem-solving skills.
- Strong leadership skills and demonstrated successes in managing a small to medium size team.
- Method validation and transfer (biochemical and biological assays) experience.
- Laboratory software (Empower, ChemStation, MODA, LIMS) and Quality Systems (TrackWise, document management system and change controls)
- Comfortable and capable of growing into a controlled manufacturing environment
- Excellent verbal and written communication skills
- Success with working with multifunctional teams (global and local)
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.