Quality Assurance Specialist II

Today, Lonza is a global leader in life sciences operating across three 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. The Quality Assurance Specialist (QA) - represents the QA department on internal and external meetings ensuring that quality requirements are met. Support manufacturing operations and all support groups related to manufacturing execution. Supports investigations using problem solving tools as owner or QA approver. Supports execution and closure of corrective actions and change controls as owner or QA approver. Review and QA approve General Manufacturing Practices (GMP) master documents and executed GMP documents from Quality Control (QC), manufacturing, material management, FE, and any other department that supports lot production. Performs material and lot release. Other duties include tracking quality records, participation in internal/external audits, QA on the floor execution, and overall cGMP compliance. Key responsibilities: Support on the floor activities, including aseptic behavior and practices Supports investigations using problem solving tools as owner or QA approver. Supports execution and closure of corrective actions and change controls as owner or QA approver. Review and QA approve GMP master documents and executed GMP documents from QC, manufacturing, material management, FE, and any other department that supports lot production. Responsible for generation, inspection and release of labels Other duties include tracking quality records, QA on the floor execution, and overall cGMP compliance Perform the Quality Assurance review and approval of GMP documents like master documents, executed documents, and quality systems records: change controls, deviations/ investigations, CAPAs and controlled documents Perform QA walkthroughs and work closely with manufacturing and support groups to resolve any issues identified during the walkthrough including quality and safety items Responsible to review and approve GMP documentation generated due to manufacturing activities (batch records, forms, log books, work orders, etc.). Key requirements: Bachelors in Life Sciences required Good Manufacturing Process compliance knowledge and related QA field Technical Writing Previous QA experience (1-3 years) in a Biotechnology and/or a pharmaceutical industry required TrackWise, DMS, SAP and LIMS system 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.