QA Specialist II

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.

QA Specialist II shop floor is responsible for real time batch record review, execution of QA walkthroughs, removal of Out-of-Service Tags, approval of suite change-overs, line clearance, product transfers, and product shipments. according to related SOPs to meet local, Global and Regulatory requirements. Through their fundamental knowledge, assists manufacturing associates by providing Quality Assurance support for operational areas involved in the execution of GMP-related activities.

Key responsibilities:

  • Review and approve GMP documentation against Standard Operations Procedures to ensure manufacturing steps are appropriately documented, observations are clear, and Good Documentation Practices are followed.
  • Conduct QA walkthroughs on the manufacturing floor for detection of non-compliance issues, inspection risks, and procedural or GMP non-compliances.
  • Perform assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
  • Approve manufacturing suite change-overs, and line clearance activities.
  • Verify release requirements for areas and equipment, and remove Out-of-service tags.
  • Identify areas of non-conformance.
  • Complete minor deviations and support root cause investigations. 
  • Revise or review standard operating procedures and submit procedural changes as needed to meet local, Global and Regulatory requirements.
  • Co-represent QA in meetings or on project teams, learning decision making as a QA representative conferring with senior staff.

Key requirements:

  • Bachelors’ Degree -Chemistry or Biological Sciences with Analytical Chemistry or Laboratory Work
  • Years of experience Pharmaceutical or Biopharmaceutical or Biotech Advanced
  • Investigate deviations and write investigations.
  • Working knowledge of applicable CTP/SOPs, GMP, FDA Regulations, application of cGMP/GDPs.
  • Maintain positive attitude in a team environment.
  • Act as an example of professionalism.

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: R31988
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