Sr. Specialist, Quality Assurance

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 has an opening for a seasoned Sr. Specialist Quality Assurance in our Bend, OR location. The role of the Specialist is to support implementation and continuous improvement of Quality Systems. This is a great opportunity to join a team that produces life-saving and life enhancing pharmaceuticals.

Key Responsibilities:

  • QA point of contact for external clients, project teams, customer notification, etc.
  • Support regulatory and client audits, perform internal and supplier audits.
  • Review Material Status Designation files
  • Controlled document and record review and approval, e.g. SOP, Validation, analytical test records, batch records, with emphasis on analytical methods, method validation and data review
  • Assist with investigations, root cause analysis and corrective and preventive action, as needed
  • Coordinate and collate site quality metrics and participate in reporting to upper management
  • Controlled documents and records review and approval
  • Make decisions during production runs with timely notice to upper management
  • Perform other duties as assigned

Key Requirements:

  • Minimum Bachelor’s Degree Preferred
  • Significant experience in pharmaceutical/biotechnology or related industry, as well as Quality Assurance
  • Quality Control experience preferred
  • Independent and flexible worker that can readily adapt to changing priorities in a fast-paced cutting-edge environment
  • Support and environment of teamwork and staff development and learning.
  • Demonstrated attention to detail and excellent oral and written communication skills
  • Auditing experience and Audit/Inspection certification preferred
  • Ability to travel 10-15%
  • Flexible Work Schedule
  • Valid Drivers’ License

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: R24262