QA Specialist, QC Systems
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 an experienced Quality Assurance Specialist, Quality Control Systems at our location in Bend, Oregon.
- Responsible for maintenance, testing, troubleshooting, calibration, qualification and repair on a variety of analytical equipment and instrumentation (includes, but not limited to the HPLC, GC, thermal instruments, dissolution equipment, balances, pH meters, and pipettors), to help ensure consistency and quality data for use in laboratory and manufacturing
- Write, execute, review and approve IQ/OQ/PM protocols and reports
- Utilizes instrument database to track calibration dates, maintenance and instrument information
- Specifies and requests purchase of components; maintains spare parts inventory
- Issues, reviews, and archives all log books and required documentation
- Coordinates with approved vendors and internal departments to schedule instrument service visits and complete work orders
- Ensures maintenance contracts and calibrations of equipment are up to date for those instruments not directly maintained
- Serves as the subject matter expert on instrumentation for consultation during normal business hours
- Trains new and current employees with best practices on instruments
- Writes, reviews and approves equipment protocols, procedures, and summary documents
- Author/approve repair/maintenance records
- Author and execute Change Controls
- Participate in client and regulatory inspections/audits
- Assist with investigations, root cause analysis, and corrective and preventative actions, as needed.
- Other responsibilities as required
- Bachelor’s degree in science or engineering. Equivalent years of experience in lieu of a degree will be considered
- Prior experience in maintenance/repair of analytical instruments is strongly desired
- Previous experience in a laboratory is preferred
- Previous experience in a GMP environment strongly desired
- Will handle hazardous materials
- Will occasionally work in confined spaces
- Must be able to work while wearing personal protective equipment
- Occasional lifting, less than 50 lbs
- Strong communication skills and successfully able to work independently and in team environments
- Ability to analyze situations and develop solutions to problems in a timely manner
- Good organization and prioritization of daily projects and tasks as well as a capacity to deal with interruptions while maintaining progress toward completing tasks
- Team oriented and willing to build positive business relationships
- Highly self-motivated and directed with proven analytical and problem-solving abilities
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.