Quality Assurance Specialist

United States, Bend (Oregon)

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.

Lonza Pharma & Biotech has an opening for a Quality Assurance Specialist at our Bend, OR location.

Key Responsibilities:

  • Perform Area Clearance events
  • Support implementation and continuous improvement of Quality Systems
  • Support development of procedures, training materials, and job aids
  • Support client interactions, project teams and audits
  • Supplier Management
  • Review Material Status Designation files
  • Controlled document and record review and approval, e.g. SOP, Validation, MBR, analytical test records, batch records
  • Assist with investigations, root cause analysis and corrective and preventive action, as needed

Key Requirements:

  • Prior experience in pharmaceutical/biotechnology or related industry
  • High School Diploma or GED required, Bachelors Degree in a life sciences field preferred
  • Knowledge of QA and FDA regulations for clinical trials materials are required
  • QC and GMP regulations (EMEA, etc.) highly desirable
  • Independent and flexible worker that can readily adapt to changing priorities in a fast-paced cutting-edge environment
  • Support an environment of teamwork and staff development and learning
  • Demonstrated attention to detail and excellent oral and written communication skills
  • Flexible work schedule. Must be available on weekends or on-call as needed on occasion

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. 

Reference: R38479