QA Inspection and Audit Associate

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.

QA Inspection and Audit Associate is responsible for supporting internal audits, global audits, customer audits, and regulatory inspection programs.  Managing assigned activities to ensure timely closure of Quality System, and that compliance risks are communicated in a timely manner.  Works closely with the team to communicate with site leadership and customers to implement effective corrective and preventive actions in response to deficiencies.  Promotes a strong culture of quality awareness and GMP compliance and supports team with continuous improvement opportunities.

Key responsibilities:

  • Act as an Auditor supporting audit planning, review recent trends and areas of concern, prepare audit checklists and the audit agenda.
  • As an Auditor, support opening and closing meetings and communicate concerns to the departments in scope.
  • Develop into a  Specialist that can identify a compliance issue, and will have an understanding of GMP implications.
  • Review and follow up on audit responses. Escalate issues to supervisor when needed.
  • Provide documentation to support the audit report.
  • Support projects and deliverables, as assigned.
  • Support in the development of materials for department and site personnel, as assigned.
  • Customer audits, regulatory inspections, and Lonza Global compliance audits.
  • Support Back Room Manager and/or Back Room staff.
  • Liaise with the site to fill front room requests from hosts. Develop the ability to disseminate information effectively or support in the front room if appropriate.
  • Support coaching SMEs on the appropriate interaction with the front room.
  • Aid in the set-up and break down of the front room and back room and audit materials

Key requirements:

  • Bachelor’s Degree - General Science, Technical Field, Regulatory Affairs
  • Intermediate years in GMP environment and/or Minimum years in Quality Assurance or similar discipline preferred; Biotechnology manufacturing background is preferred
  • Direct exposure to Regulatory Inspections and Customer Audits
  • Advanced knowledge of  cGMP’s and regulations
  • Strong written and verbal communication skills are required

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: R30326