QA Specialist III (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.
The QA Specialist III role at Lonza AG offers an outstanding opportunity for an ambitious professional to join our outstanding team in Houston, TX. This position is pivotal in ensuring flawless compliance with regulatory requirements in our fast-growing Health Care sector. You will play a crucial part in our dynamic environment, where your proven track record will help us achieve our world-class standards.
Key responsibilities:
Verify the company's compliance with ISO/cGMP quality system requirements, including 21CFR210, 211, 610, and Good Manufacturing Practices.
Provide immediate, on-the-floor support to Quality Control and quality control staff to address compliance-related concerns.
Reviews and approves executed QC documentation (test records, lab investigations, system suitability, stability reports, assay qualification protocols/summary reports, environmental monitoring, etc.)
Manages deviations and change controls as owner or QA approver in Trackwise system
Writes/revises/approves master documents Ex. Forms, Standard Operating Procedures (SOPs), specifications, etc.
Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
Prioritize and manage multiple projects simultaneously.
Review and approve ASSAY validation documents.
Key requirements:
Bachelor's degree in a scientific or technical field.
Minimum of 5 years of experience in a cGMP environment and related QA field.
In-depth knowledge of GMP compliance, including 21CFR210, 211, 820, and the PICS Guide to Good Manufacturing Practices.
Familiarity with Aseptic Processing, and Part 11 compliance.
Outstanding time management skills and the ability to manage multiple projects concurrently.
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.
