Senior QC Specialist, Quality Control Enterprise Systems - LSA (Biotech)
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.
Key responsibilities:
- Ensure regulatory requirements and Lonza policies pertaining to analytical instruments and computer software applications are met
- Implement QC analytical instrument and software validation requirements, draft GMP procedures, validation documents, and conduct test scripts
- Approve final project documents and write final validation summary reports
- Maintain the Data Integrity of the Enterprise applications (Empower, gLIMS, Thermo LIMS, and MODA) in line with 21 CFR Part 11 and other relevant regulatory requirements
- Develop continuous improvement of Enterprise applications to improve compliance and operational efficiency
- Collaborate closely with IT/OT, Quality Control (QC), Manufacturing (MFG or equivalent experience), and Quality Assurance (QA) to effectively and efficiently implement new systems, system upgrades, or modifications
- Perform technical, root-cause analysis for complex system issues or errors and complete recommended solutions
- Perform user and application software administration on Enterprise and analytical systems
- Work on troubleshooting assignments that are complex in nature where considerable judgment and initiative are required in making creative and effective recommendations to solve problems
- Recommend and implement analytical instrument and software engineering controls for Analytical systems and Enterprise applications
- Act as Subject Matter Expert (SME) during regulatory and customer inspections and audits
- Perform all aspects of Quality Management System (QMS) processes, including Change Control, Deviations, Corrective and Preventive Actions (CAPAs), and Tasks
- Write, review, assess, and/or approve change controls for analytical instruments and software used in QC laboratories and manufacturing
- Remain up to date on all assigned training activities
Key requirements:
- Bachelor's degree in a related field or equivalent experience
- Minimum of 5 years of experience in a quality control or manufacturing environment
- Proven expertise in regulatory requirements and compliance, specifically 21 CFR Part 11
- Experience with Enterprise applications such as Empower, gLIMS, Thermo LIMS, and MODA
- Strong analytical and problem-solving skills with the ability to perform root-cause analysis
- Outstanding collaboration and communication skills to work with cross-functional teams
- Ability to manage multiple projects and priorities in a fast-paced environment
- Experience acting as SME during inspections and audits
- Strong understanding of QMS processes and documentation
- Dedication to continuous improvement and operational efficiency
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.
