Quality Assurance Compliance Specialist Level III (Biotech)
Today, Lonza is a global leader in life sciences operating across five 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 AG is continually growing and evolving, offering dedicated individuals' opportunities to join our team! This role is to serve Lonza Subject Matter Expert (SME) as QA oversight on QC driven tasks. Interacts directly with internal and external customers to obtain documentation required for document processing. The individual also manages investigations or change controls related to QC as owner or QA approver. Performs master document review and approval for any QC related documentation.
Key responsibilities:
Reviews and approves executed QC documentation (test records, lab investigations, system suitability, stability reports, assay qualification protocols/summary reports, environmental monitoring, etc.)
Provide QA oversight in deviation investigation, discrepancy reports and CAPA implementation.
Participate actively, utilizing Root Cause Analysis tools to enable effective and timely closure of records.
Provides Quality Change Request oversight for Lab service changes.
Supports review and approval of master documents Ex. Forms, Standard Operating Procedures (SOPs), specifications, etc.
Liaise with cross functions, communicating information, obtain documentation and updates in timely manner.
Develops good working relationships with internal & external customers.
Applies GMP knowledge to ensure that QC processes comply with effective procedures and regulatory requirements.
Maintains compliance with all required training and assists with training of fellow analysts.
Performs project-related tasks as assigned.
Performs other duties as assigned.
Key requirements:
Bachelor's degree in Life Sciences or a related field.
5-10 years of experience in Quality Assurance or a related role.
Proven track record to review and approve QC documentation.
Proven understanding of GMP and regulatory requirements.
Outstanding communication and collaboration skills.
Ability to resolve and efficiently implement effective QA processes.
Experience with Root Cause Analysis and CAPA is highly desirable.
Ability to work under general supervision and balance multiple tasks efficiently.
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.
