Lonza
QA Specialist IV-QAIAM
Posted
Apr 24, 2025
Job ID:
R67553
Location
Portsmouth, NH
Hours/week
40 hrs/week
Payrate range
Unknown
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.
- 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.
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