Lonza
Quality Lead (Greenwood, SC - Onsite)
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.
Join Lonza AG to make a difference in life sciences. As a Quality Lead in Greenwood, SC, ensure top quality for dietary supplements in a collaborative, improving environment.
Key responsibilities:- Manage the total quality relationship with key customers as defined by the business.
- Coordinate customer audits and regulatory inspections to ensure compliance with industry standards.
- Supervise the Quality Coordinator and Sr. QA Coordinator roles within the DFS quality organization, encouraging a culture of excellence.
- Coordinate core Quality Systems, including Deviations, Change Control, and CAPAs, to maintain flawless operations.
- Compile and report monthly metrics related to quality systems, using data to drive informed decisions.
- Assist the QA Manager in developing the annual quality plan, contributing to our ambitious goals.
- Serve as the chair of the Quality Council team for DFS, leading initiatives that improve our quality systems.
- Coordinate periodic SOP/SOI/WI reviews and write SOIs/WIs where applicable, ensuring strict adherence to protocols.
- Identify and implement potential improvement projects that elevate our standards.
- Coordinate and lead all aspects of annual cGMP training as vital, ensuring our team is equipped with world-class knowledge.
- Develop procedures and controls to support the Quality Management System.
- Act as the sanitation supervisor for the DFS site, maintaining outstanding hygiene standards.
- Perform risk assessments in support of quality decision-making, ensuring the highest levels of safety.
- Review, approve, and manage Quality Documents related to Master Batch Records and other specifications.
- Assist in approving or rejecting raw materials and finished goods as needed.
- Perform second review and disposition of batch records as vital.
- Support scheduling and maintaining contract calibration services.
- Serve as back-up for DFS QA Coordinator.
- Perform other duties as assigned.
- Bachelor’s Degree or equivalent experience in Business, Science, or a related Technical field.
- Sophisticated statistical training and ASQ certification preferred.
- Computer literate with proficiency in Word, Excel, PowerPoint, and other programs.
- Familiarity with SAP functionality.
- Excellent written and verbal communication skills.
- Ability to represent the company effectively with customers.
- Effective great teammate with a collaborative spirit.
- Ability to work the required shift and overtime, including weekends or holidays as needed.
- Attendance on plant/office site is essential.
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 insights in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The happiness that comes with making a relevant 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.