Job: QC Analyst, Lonza, Durham, NC
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.
QC Analyst responsible for performing and developing QC assays. Lead, perform and document routine assays as well as develop, transfer, and train other on complex hepatocyte, hemopoeitic and clonetic test methods. Performs data review of test records and documentation related to Cell review Committee and other quality documentation. Will represent Quality Control, Research cells on related project meetings. Authors, revises and reviews procedures and test methods.
Responsible for mentoring and training other QC Analysts. Able to troubleshoot assays
Able to assist in workflow planning
Able to develop assays as needed for projects
Oversee and participates in tech transfer and development of required QC research cells and other assays as required, in close association with R&D
Responsible for overseeing and shipment of samples to other CTO for assays not performed at Lonza-Durham. Includes coordination of shipping and data management
Author and revises SOPs, Forms and Test Records. Initiates CRC forms and complete necessary documentation
Lead QC electronic data integrity compliance
Adheres to Good Documentation Practices
Responsible for performing testing activities with other duties as assigned
Responsible for maintaining training requirements up to date
Performance of assays and documentation must comply with Quality systems in place, and adhere to Lonza SOPs
Perform other duties as assigned
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.
-BS/MS with at least 5-10 years relevant experience
-At least 3 years of cell culture testing experience preferably from multiple tissues and organs
-Aseptic practices and knowledge of scientific processes and writing SOPs
-Knowledge of biology, cell biology, anatomy, and chemistry concepts
-Hemocytometer cell counting experience required
-Knowledge of ICC, Flow Cytometry and RT-PCR would be preferred
-Computer software skills and knowledge in data integrity compliance. Organization, record keeping and planning skills, budget preparation skills, training skills, ability to manage multiple projects, time management skills, facilitation skills
Diplomacy, negotiation skills, written and oral communication skills, team building skills, independent work skills, strong work ethic
-Coaching and delegating skills
-Strong, customer focused philosophy
-Ability to professionally converse with customers about highly technical concepts
-Strong attention to detail
-Exhibits flexibility due to changing human tissue availability and production needs
-Strong work ethic