Job Description

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.

Join our highly motivated team at Lonza AG in Houston, TX and play a key role in maintaining compliance and quality. As a Quality Assurance Specialist IV, Audit and Inspection, you will chip in to our growth and success in the life sciences industry. Take this chance to create a real impact and excel in quality assurance.

Key responsibilities:

• Lead and complete internal audits of the Lonza Houston QMS independently and highlight potential inspection compliance risks to GMPs and various Health Authority regulations.
• Provide mentorship for timely remediation and response writing to gaps identified in internal and customer audits and Health Authority inspections.
• Advise, guide, and support the site in regulatory inspections and customer audits.
• Lead site preparation for customer and Health Authority inspections. Support these inspections by identifying key potential risks and weaknesses in site performance and adherence to the QMS.
• Collaborate with internal collaborators and QA to ensure that CAPA(s) raised from internal, customer, or Health Authority audits are SMART. Ensure timely closure of CAPAs.
• Act as a site guide on Health Authority regulations and provide regular training and leadership to internal customers regarding current industry GMP developments and adherence to GMPs.
• Maintain excellent knowledge and adherence to all relevant Health Authority and industry practices, codes, standards, and regulatory requirements.

Key requirements:

• Bachelor of Science in Life Sciences, Engineering or equivalent experience.
• Significant (5-10 years) QA experience within a GMP regulated environment (ideally an aseptic environment).
• Experience working within a GMP regulated pharmaceutical environment.
• Experience with regulatory (e.g. MHRA & US FDA, etc.) requirements and inspections.
• Good problem solving and analytical skills.
• Effective communication skills that lead collaborators to successful compliance to QMS standards.
• Ability to efficiently train and educate others in relevant Health Authority regulations.
• Ability to prioritize and plan independently in a fast-paced manufacturing environment.
• Ability to engage in teamwork and work independently.

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.

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