Lonza
Senior Quality Assurance Specialist-Audits and Inspection
Lonza, Portsmouth, New Hampshire, United States, 00215
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 a Senior Quality Assurance Specialist-Audits and Inspection, where you'll play a pivotal role in maintaining our world-class compliance standards. This role has been built to support our ambitious growth, ensuring flawless execution of audits and inspections. Located in New Hampshire, USA, you will have the crafted opportunity to drive continuous improvement activities and maintain inspection readiness, making a significant impact on our operations. Key responsibilities:
Maintain Compliance Risk Register for CT Quality. Coordinate, facilitate, and support internal and external audits and regulatory inspections. Develop, improve, and monitor the Quality System for CT. Write and approve Standard Operating Procedures (SOPs). Continuously improve areas impacted by deviations and approve relevant deviations and CAPAs. Coordinate, support, and author audit and inspection responses with SMEs. Strive to maintain the highest level of inspection readiness at all times. Accurately address weaknesses and mitigate gaps in procedures, processes, and policies to ensure compliance with Annex 1 and appropriate CFRs. Manage and track Key Performance Indicator Quality Metrics. Collaboratively work with team members, collaborators, and customers to conduct internal audits as necessary. Foster a culture of quality by mentoring collaborators on GMP principles. Mentor and train other quality team members. Perform other duties as assigned. Key requirements: Proven experience in quality compliance, particularly in audits and inspections. Outstanding organizational, analytical, and technical skills. Strong ability to multitask and prioritize work in a dynamic environment. Excellent written and verbal communication skills. Established ability to develop and maintain positive connections with team members, customers, clients, and partners. Expertise in managing and tracking quality metrics. Ability to mentor and train team members effectively. Dedication to maintaining a state of inspection readiness and driving continuous improvement.
We are excited to find someone who is as passionate about quality and compliance as we are. If you are ready to compete at an exceptionally high level and contribute to our mission, we would love to hear from you.
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.
Join Lonza AG as a Senior Quality Assurance Specialist-Audits and Inspection, where you'll play a pivotal role in maintaining our world-class compliance standards. This role has been built to support our ambitious growth, ensuring flawless execution of audits and inspections. Located in New Hampshire, USA, you will have the crafted opportunity to drive continuous improvement activities and maintain inspection readiness, making a significant impact on our operations. Key responsibilities:
Maintain Compliance Risk Register for CT Quality. Coordinate, facilitate, and support internal and external audits and regulatory inspections. Develop, improve, and monitor the Quality System for CT. Write and approve Standard Operating Procedures (SOPs). Continuously improve areas impacted by deviations and approve relevant deviations and CAPAs. Coordinate, support, and author audit and inspection responses with SMEs. Strive to maintain the highest level of inspection readiness at all times. Accurately address weaknesses and mitigate gaps in procedures, processes, and policies to ensure compliance with Annex 1 and appropriate CFRs. Manage and track Key Performance Indicator Quality Metrics. Collaboratively work with team members, collaborators, and customers to conduct internal audits as necessary. Foster a culture of quality by mentoring collaborators on GMP principles. Mentor and train other quality team members. Perform other duties as assigned. Key requirements: Proven experience in quality compliance, particularly in audits and inspections. Outstanding organizational, analytical, and technical skills. Strong ability to multitask and prioritize work in a dynamic environment. Excellent written and verbal communication skills. Established ability to develop and maintain positive connections with team members, customers, clients, and partners. Expertise in managing and tracking quality metrics. Ability to mentor and train team members effectively. Dedication to maintaining a state of inspection readiness and driving continuous improvement.
We are excited to find someone who is as passionate about quality and compliance as we are. If you are ready to compete at an exceptionally high level and contribute to our mission, we would love to hear from you.
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.