QC Program Coordinator Lvl III
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 in Portsmouth, NH is searching for a Quality Control Senior Program Coordinator to join our growing QC team. The Quality Control Senior Program Coordinator also acts as a liaison between the Quality Control Laboratory and its internal and external customers. As our Quality Control Senior Program Coordinator, you will be responsible for the management and execution of stability studies in the Quality Control Laboratory, completion of all program projects, and mentor other Program Coordinators. This position sets up stability studies, performs stability pulls, tracks stability testing, ships samples to contract labs and creates stability reports. Additional responsibilities will include tracking QC testing, managing project commitments, following through on action items, coordinating analytical teleconferences and participate in problem solving of issues. Please note this is a Senior role!
- Participates on multiple customer project teams as the Quality Control representative
- Tracks and compiles product data to present to internal and external customers and drives associated process change controls and deviations
- Coordinates efforts between manufacturing, customer and Quality Control to assure that testing is prioritized, completed on time and communicated in an effective and timely manner.
- Creates, revises and reviews Good Manufacturing Practices (GMP) documentation including stability protocols and reports
- Sets up stability studies, performs stability pulls and shipments of stability samples to customers and contract labs.
- Coordinates and compiles Quality Control data for Quality Assurance/Quality Control management review and the timely release of product.
- Tracks stability samples and coordination with testing laboratories.
- Bachelor or Associates Degree preferred. Area of study in Microbiology, Biochemistry or Related Science Fields.
- Significant working experience within cGMP industry in a QC laboratory.
- Substantial experience using GMP Quality Systems (ex. TrackWise, LIMS).
- Excellent communication skills with the ability to collaborate across multiple teams and projects.
- Strong computer skills.
- Ability to exercise judgment within defined practices and policies in selecting methods and techniques for obtaining solutions and/or taking appropriate actions.
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.