QA Raw Materials Compliance Specialist
United States, Portsmouth (New Hampshire)
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.
The Raw Materials Compliance Specialist interacts directly with Lonza’s internal and external customers for disposition of materials, resolution of release issues and other material related work as needed. As an established Subject Matter Expert (SME) in the material receipt, testing and disposition process, they will be expected resolve complex issues, triage issues for escalation to area management and train junior staff members. They will provide resolution to escalated issues within their area of responsibility and will help define the strategy for remediation of escalations/issues and improvements efforts. The Specialist will also be expected to perform all associated SAP transactions as part of the release as well as other Quality functions within SAP. They will require little direction and coaching for day to day activities, are expected to be subject matter experts to the associated workflows and able to manage the escalation of issues.
- Review, manager and ensure compliance with GMP regulations for raw materials pertaining to commercial manufacturing
- Serves as the SME for internal and external customers on technical transfers
- Works with project teams to on-board raw materials
- Update and revise SOPs as required to ensure compliance
- Keeps up to date with compliance and regulation guidelines within the industry
- Understands and makes informed decisions pertaining to testing and testing selections for materials
- Bachelor’s Degree, preferred area of study in biology, biochemistry or other science degree
- Substantial experience working within a GMP regulated Biotech or Pharmaceutical industry
- Significant knowledge of GMP regulations for commercial manufacturing as relevant to raw materials
- Experience in testing and test selection raw materials
- Experience supporting technical transfers desired
- Ability to make independent decisions based off industry and regulations knowledge
- Experience in on-boarding raw materials
- Effective communication skills, written and verbal and the ability to partner and collaborate with partners from various functions
- Experience with SAP or similar ERP system
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 it is 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.