Quality Assurance Specialist
United States, Bend (Oregon)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
Lonza Pharma & Biotech has an opening for a Quality Assurance Specialist for their Bend, OR location.
As a Quality Assurance Specialist, you will be responsible for performing day-to-day tasks of the Quality Assurance Department in a GMP (Good Manufacturing Practices) facility manufacturing clinical and commercial pharmaceutical products.
- Conduct investigations and write deviations for product impact, root cause, and CAPA (Corrective Action/Preventive Action)
- Review and approve controlled documents and records (e.g. SOPs (Standard Operating Procedures)), validation, batch records, analytical test records, and materials
- Coordinate generation of APR (Annual Product Review) documents
- Generate and report Quality metrics
- Support and/or lead Quality System continuous improvement implementation/project management
- Bachelor’s degree in Chemistry, Biology, or other scientific related discipline is required
- Previous GMP experience in Operations, Quality Assurance, or Quality Control is required
- Flexible work schedule; must be available to work on weekends, as needed
- Knowledge of FDA (Food and Drug Administration) and EU (European Union) guidance and regulations for Clinical and/or Commercial manufacturing and support functions (e.g. labs, warehouse, and facilities, etc.)
- Regional regulatory knowledge preferred (i.e. Canada, Japan, and Brazil)
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.