Quality Assurance Specialist, Audit and Inspection

United States, Houston (Texas)

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 Assurance (QA) Specialist in Audit and Inspection interacts directly with External Customers, Regulatory Inspectors, and Internal Stakeholders.  The role reports to the Audit & Inspection Manager, responsible for being a leader in regulatory inspections, customer audits and audit management. This role will have responsibility for and support the internal audit program and site leadership throughout the inspection/audit process to ensure optimal outcomes and a state of continuous inspection readiness.

Key responsibilities:

  • Advise, guide and support the site in regulatory inspections and customer audits
  • Participate in and lead site preparation for inspections and audits
  • Provide guidance for timely remediation and response writing
  • Work with QA and other departments to ensure that Corrective and Preventive Actions (CAPA) raised as a result of the above are SMART and that CAPAs are closed by the due dates.
  • Able to direct appropriate follow up with internal stakeholders on audit responses and CAPA assignments related to inspections, customer audits, internal audits and inspection readiness findings.
  • Excellent knowledge and adherence to all relevant codes, standards and regulatory requirements
  • Able to develop skill as an internal Good Manufacture Practices(GMP) auditor.
  • Any other tasks as and when assigned by manager/ supervisor.

Key requirements:

  • Bachelor Degree in Life Sciences discipline with advanced years of experience required in the Quality Assurance Field.
  • Experience working within a GMP-regulated pharmaceutical – ideally biologics or bio-pharmaceutical – environments and/or relevant QA experience
  • Experience with regulatory (e.g., MHRA & US FDA, etc.) inspections
  • Good problem solving and analytical skills
  • Good communication skills
  • Decision Making
  • Planning/Organizing
  • Effective Communication
  • Personal Orientation
  • Teamwork

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: R28240
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