Job Description

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there\xe2\x80\x99s 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\xe2\x80\x99s the kind of work we want to be part of.

is actively seeking a Supplier Quality Specialist (SQS) to be responsible for establishing processes and developing relationships with suppliers to ensure that received products are free of defects. The SQS troubleshoots quality issues, assesses supplier risks, analyzes defect trends, and leads continuous improvement projects to increase the supplier capability of consistently meeting Lonza requirements. Also, the SQS acts as an independent Internal/Supplier Auditor for Personalized Medicine Lonza Quality System and liaises with conformity assessment bodies on maintenance of EMC/Safety certifications.

This position has a Monday \xe2\x80\x93 Friday, workday schedule and is located at our Kingston, ON site.

Key responsibilities:

• Oversees the supplier qualification and re-evaluation for our suppliers;
• Follow up on Supplier Corrective Action responses and supplier change notification.
• Review supplier quality agreements
• Ensure compliance with national and international regulations and chemicals legislation;
• Lead the internal audit process as independent auditor to the QMS.
• Direct involvement and interface with internal and external auditors, including clients/notified bodies, relating to all activities, reports and files associated with Quality System.
• Develops and maintains Quality System procedures that are compliant with FDA 21 CFR 820, ISO 13485, ISO 9001 and other regulatory /client requirements.

Key requirements:

• Bachelor\xe2\x80\x99s degree in Engineering or Science required. Certification in Quality Management, preferred.
• 5 years of working experience in a medical device, pharmaceutical or regulated biotech industry, preferred.
• Ability to problem solve and troubleshoot.
• Strong computer skills and proficiency in written and verbal communication
• Thorough knowledge of cGMP/GLP /ISO 13485/ US FDA 21 CFR 820/ EU Directives/ ICH 9/ ICH 10 required.
• Must be able to work in a team environment and have good interpersonal skills.
• Must be willing to work on the shop floor as well as in the office.
• Must have strong organizational skills and be able to manage and prioritize multiple assignments at one time, including the ability to follow assignments through to completion and meet deadlines;
• Must be able to communicate status, needs, risks and timelines effectively to management.

Every day, Lonza\xe2\x80\x99s 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.

Lonza