QC Data Reviewer

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 Data Reviewer is responsible for the comprehensive review of data generated from the Quality Control Laboratory. The QC Data Reviewer will specialize in the data review of two of three QC teams (Microbiology, Chemistry, or Biochemistry).  The data reviewer ensures the laboratory is following applicable regulatory and compliance procedures (GMP, good documentation practices, etc.), including Lonza’s policies. The QC data reviewer also reviews laboratory equipment use logs, annual instrument qualifications, and other data as needed.

Key responsibilities:

  • Data documented by laboratory personnel within laboratory notebooks, worksheets, and logbooks.
  • Electronic audit of data generated from QC analytical systems
  • Data generated by external vendors, both hard-copy reports
  • 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.
  • Updating KPIs related to data review such as documentation error, turnaround time, and leads improvement projects.
  • Assist in the updating of worksheets and laboratory procedures as needed
     

Key requirements:

  • Required experience: Intermediate to advanced years of Laboratory Quality Control experience preferably in Biopharmaceutical or Pharmaceutical industry
  • Preferred laboratory data review experience
  • Working knowledge of USP, JP, EP and other regulatory agencies/groups as related to good documentation practice and data review
  • Familiarity of laboratory software such as Empower, Chemstation, MODA, LIMS, SoftMax Pro, WinkQCL, etc.
  • Comfortable and capable of growing into controlled manufacturing environment
  • Excellent verbal and written communication skills

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: R38478
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