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QA Specialist IV-QAIAM

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Today, Lonza is a global leader in life sciences operating across five 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 Lonza AG as our next QA Specialist IV-QAIAM and be part of our ambitious journey to achieve world-class quality standards! This role in New Hampshire, USA, is pivotal in ensuring our operations meet the highest regulatory and customer expectations. As we continue to grow, your contributions will be essential to maintaining our flawless compliance record.

Key responsibilities:

Support the implementation and execution of the Internal Audit Report and Annual Internal Audit plan.
Act as a PQR SME and support internal/global, customer, and regulatory inspection programs.
Conduct training and walkthrough audits, providing feedback and observations to Area Owners.
Manage assigned activities to ensure the timely closure of Quality System Records and communicate compliance risks.
Collaborate with area management, senior leadership, and customers to implement effective corrective and preventive actions.
Promote a strong culture of quality awareness and GMP compliance, actively pursuing opportunities for improvement.
Train to be a lead internal auditor, conducting Internal Audit preparations and completing activities associated with internal audits.
Prepare for customer audits and manage quality records ownership and observation responses.
Train to host customer audits and support Regulatory Inspections preparation, acting as back room managers.

Key requirements:

Bachelor’s degree or equivalent experience required.
Proven experience in quality assurance within a regulated environment.
Outstanding understanding of GMP compliance and quality systems.
Strong ability to manage multiple tasks and communicate compliance risks effectively.
Demonstrated experience in conducting audits and implementing corrective actions.
Ambitious approach with a dedication to continuous improvement.
Excellent teamwork skills to work closely with various collaborators.
Ability to successfully implement quality initiatives and maintain strict compliance standards.

Embrace this outstanding opportunity to contribute to our mission and compete at the highest levels of quality assurance. Join our team and help us make a meaningful, positive impact on millions of lives!

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.

Quality Assurance GMP Auditing Compliance Life Sciences

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$87500 / YEARLY (est.)

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$80000K

$95000K

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