QC Scientist 1

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.

QC Scientist I will act as a team member of the Quality Control department to support technology transfer, validation, and/or investigation projects. Subject Matter Expert for one or more disciplines (Chemistry, Microbiology or Biochemistry). Technical writer of test methods, protocols, and reports.  Acts as advisor to junior staff to meet schedules and/or resolve technical problems.  Provides guidance to junior staff to achieve goals in accordance with established policies.

Key Responsibilities:

  • Writes method transfer and validation protocols including reports
  • Performs method transfers and method validations
  • Performs qualification and validation of electronic equipment
  • Leads Quality Records such as Laboratory Investigations, CAPAs, Change Controls, and Deviations
  • Creates, revises and reviews quality GMP documents, i.e. local SOPs and assay worksheets
  • Attends project team meetings and represents the QC laboratory
  • Performs routine testing of raw materials, in-process, and bulk drug substance samples
  • Acts as the subject matter expert on one of three disciplines (chemistry, biochemistry or microbiology)
  • Participates and supports regulatory audits
  • Independently drive projects to on-time completion
  • Other – such as leading OE initiatives, Improvements, hiring of staff
  • Perform other duties as assigned.

Key requirements:

  • Bachelor  degree  and/or Advanced Graduate degree (MS/PhD)
  • Preferred area of study:  Microbiology, Biochemistry or equivalent science field
  • Preferred ­­­­5+ years in a GMP/Professional environment
  • Use of Microsoft Suites (Word, Excel, Powerpoint)
  • Use of Laboratory computerized systems such as Empower, MODA, WinkQCL, LIMS, Chemstation and other supporting software.
  • Use of GMP Quality Systems such as: TrackWise, LSO and DMS
  • Very strong communication skills both written and verbal.
  • Able to speak and convey messages and or information publicly.
  • Makes quality decisions independently and also with guidance from Manager.

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: R40365