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.
The main task of the QA Specialist IV is to assess and approve GMP documentation related to Site operations, covering Engineering, Facilities, Validation, MES, and Quality Control. This position is outstanding as it functions as an SME for QA document review pertaining to Equipment/Instrumentation, Validation Maintenance, and relevant Computer and Analytical Systems. Additionally, the QA Specialist IV supports certain customer-specific documentation, allowing you to demonstrate expertise in a team-oriented setting. You will lead the team, mentor junior members, and engage with other QA Specialists, QA PMs, and Management to aid Site operations!
Key Responsibilities:
Review and sanction documents like SOPs, Work Instructions, eBR and Automation Documentation, Forms & Checklists, and other materials within a Document Management System.
Review and authorize Validation / Qualification documents in electronic or paper format, such as Protocols & Summary Reports for Equipment/Instrumentation, Validation Maintenance, and applicable Computer and Analytical Systems.
Evaluate non-DMS documents, including QA Monthly Preventative Maintenance, Engineering Preventative Maintenance documents, CMMS Forms, Instrumental Data Sheets, and more.
Follow Lonza’s documentation review procedures, ensuring changes are justified appropriately and accurately reflected in documents.
Advance problems and worries to management as necessary, collaborating with internal customers to address them.
Participate and drive interdepartmental projects, ensuring successful implementation.
Develop, schedule, and maintain team training and standard work.
Serve as a role model and educator for the team on pertinent topics.
Engage in routine meetings, data queries, and report section compilation as assigned by management.
Apply Data Integrity principles in all aspects of work, aligning with Lonza DI policies, guidelines, and procedures.
Consistently develop skills in reviewing and pinpointing areas for team growth.
Qualifications:
A Bachelor's degree or equivalent experience in Life Science is required; a combination of education and experience may be considered.
5-10 years of advanced experience in Quality Assurance within a Pharmaceutical, Biotech, or GMP environment.
Strong understanding and knowledge of GMP regulations (e.g., ICH Q7-Q11, CFR 210, 211, 600-680, 820, etc.).
Excellent written and verbal communication skills at all levels.
Proficiency with Microsoft Office Tools (e.g., Word, Excel, Outlook, and PowerPoint) preferred.
Experience with enterprise systems such as DMS, TrackWise, SAP, Syncade, etc., is preferred.
Eager individual who pays close attention to detail and can adjust to shifting priorities.
Ability to work effectively both individually and within a team environment with direction as required.
Ability to present facts clearly and logically while understanding other perspectives.
Skills for recognizing and addressing critical issues independently or collaboratively.
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.
Top Skills
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
