QA Specialist II - Raw Material

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 Quality Specialist – Raw Material interacts directly with Lonza’s internal customers for disposition of materials.

These interactions will require frequency collaboration with these internal customers and will require the Specialist to work in those areas as needed.

Using a deeper understanding of cGMP documentation, the Specialist II will review material release documentation as well as other ancillary attachments such as vendor technical documentation, certificate of analysis/compliance and confirmatory test results, in order to ensure the timely release of raw material for production.  Due to the Specialist II deeper understanding of the material receipt, testing and disposition process, they will be expected to triage and resolve more complex issues. They will provide input on issues within their area of responsibility to Quality supervisor or management for resolution and/or improvements. The Specialist II will also be expected to perform all associated SAP transactions as part of the release as well as other Quality functions within SAP.

They will be expected to be familiar with established workflows and the associated policies.

Key responsibilities:

  • Support the revision of raw material specifications.
  • Independent review of material release documentation. Work with inspection service provider on issues.  Collaborate with Hayward manufacturing, Supply Chain and QC teams to address priority changes and issues preventing the disposition of materials.
  • Support the management of non-conforming material.
  • Initiate and manage deviations and CAPAs to closure.
  • Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.  Must comply with safety policies of the company and site.
  • Adherence to cGMPs is required at all times during the manufacture of Hayward Lonza products. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
  • High output while multi-tasking required
  • Perform other duties as assigned

Key Requirements:

  • Bachelor's Degree or Associates with equivalent experience in a QA or Operations related background. Preferred area of study:  Life sciences.
  • Experience in GMP environment preferred.  Biotechnology manufacturing background is preferred.
  • Knowledge of GMP’s and regulations
  • Experience with Trackwise, SAP, and Microsoft Windows preferred
  • Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities, attention to detail, works effectively individually and with team

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: R25574