Manufacturing Specialist, Quality Assurance

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 Manufacturing Specialist, Quality Assurance at our Bend, OR location.

Key Responsibilities:

  • Perform Area Clearance events
  • Status labeling of product, such as QA Hold/Rejected
  • Review Production Records for accuracy and compliance
  • Support implementation and continuous improvement of Quality Systems
  • Oversee product compliance during product manufacturing
  • Recommend compliance enhancements to the Manufacturing area
  • Assist with manufacturing investigations, root cause analysis, and corrective and preventive actions, as needed
  • Assure that the manufacturing of product is performed according to SOPs and current GMPs
  • Communicate and escalate potential non-compliant and adverse events to QA Management

Note:  Schedule will be 4 ten hour shifts Wednesday through Saturday. During initial training and onboarding, schedule will be 5 eight hour shifts Monday through Friday.

Key Requirements:

  • Experience in pharmaceutical/biotechnology or related industry
  • Independent and flexible worker that can readily adapt to changing priorities in a fast-paced cutting-edge environment
  • Knowledge of QA and FDA regulations for clinical trials materials
  • Experience with operational deviations and global investigations participation strongly preferred
  • Demonstrated attention to detail and excellent oral and written communication skills
  • Must be available on weekends or on-call occasionally as needed
  • Must be able to work while wearing personal protective equipment

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: R38246