Quality Assurance Validation Specialist
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 Quality Assurance Validation Specialist in our Bend, OR location. The role of the Quality Assurance Validation Specialist is to ensure that equipment, instruments, and systems are qualified for their intended purpose, and that analytical methods, equipment cleaning and manufacturing processes are validated appropriately. The Quality Assurance Validation Specialist also ensures that quality systems procedures are followed and that regulatory requirements are met. This is a great opportunity to join a team that produces life-saving and life enhancing pharmaceuticals.
- Support the qualification of process and facility equipment, analytical instruments, and computer systems, as well as cleaning and process validation.
- Write, execute, review and approve validation protocols, reports, and system lifecycle documents, as required.
- Collaborate across functions, including IT, QC, Development, Engineering/Automation, Operations, QA, and Vendors, as required, to execute qualifications and validations.
- Support the change control program, and perform assessments as part of change and risk management.
- Participate in client and regulatory inspections.
- Assist with investigations, root cause analysis, and corrective and preventative action, as needed.
- Significant experience in pharmaceutical, biotechnology or related industry, with working experience in quality assurance or quality control
- Experience performing quality reviews in regulated company, including change control
- Experience with equipment, instrument, and system qualification, and process and/or cleaning validation
- Demonstrated attention to detail and excellent oral and written communication skills
- Working knowledge of GxPs, Regulations (such as 21 CFR Part 11, 210, 211 & Annex 11, 15), and related industry standards (such as USP, ASTM)
- Personal Protection Equipment
- Occasional light lifting, less than 25 lbs
- Flexible work schedule
- Travel as needed
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.