Quality Specialist 2

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 dedicated 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.

At Lonza AG, we are dedicated to providing elite innovative solutions in life sciences. Our Personalized Medicine division is growing, and we are looking for a bold Quality Specialist 2 to join our team in Kingston, ON, Canada. This role is central to ensuring the compliance and quality of our groundbreaking Cocoon® Platform, which supports the development of personalized cell therapies. If you are passionate about making a difference in the world and want to be part of an especially hard-working team, this is the opportunity for you

**Key responsibilities**:

- Participate in review meetings for Deviation, CAPA, Complaint, and Change Control, and assist in providing training on Quality System processes.
- Support the implementation of systems and procedures to ensure compliance with Lonza’s standards and regulations.
- Maintain logs and quality records related to Quality System processes, including complaints, deviations, change control, and CAPA. Identify and advance risks and trends.
- Participate in internal and supplier audits to support Quality System requirements.
- Actively participate in audits conducted by Lonza Corporate, customers, and certification bodies.
- Serve as the Quality Assurance representative in simple new product introductions, design, and process change projects.
- Collaborate with process owners to establish and maintain standards, guidelines, and procedures as per Lonza QMS.
- Support investigation leaders in root cause analysis and risk mitigation for customer complaints and deviations, providing mentorship and expertise.
- Identify quality risks and collaborate with leaders to craft and implement effective mitigation strategies.
- Develop and provide training within the department and to external collaborators.
- Act as a backup for other Quality Specialists and Quality Control Technicians.
- Support continuous improvement activities, corrective action planning, and customer happiness initiatives.
- Support continuous improvement programs to establish effective Quality Management Systems.
- Own quality records such as change controls, CAPAs, investigations, and efficiency checks in line with valid SOPs.
- Review and approve records such as Standard Operating Procedures (SOPs), Master Manufacturing Batch Records, Material Specifications, Quality Risk Assessments, Deviations, CAPAs, Change Requests, Efficiency Checks, Testing Protocols, and Reports.
- Independently drive simple projects to accurate completion.

**Key requirements**:

- University or College diploma in Engineering, Science, Mechanical or Electronic field.
- Possess strong digital literacy and proficiency in both written and verbal communication.
- Excellent communication and collaboration abilities.
- Basic understanding and experience of quality assurance principles and regulatory requirements.

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 sophisticated 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 relevant difference.