QA Raw Materials Compliance Specialist II
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 Raw Materials Specialist interacts directly with Lonza’s internal customers for disposition of materials. Using a deeper understanding of cGMP documentation, the Specialist will review material release documentation as well as other ancillary attachments such as vendor technical documentation, certificate of analysis/compliance and confirmatory test results, in order to ensure the timely release of raw material for production. Due to the Specialist established understanding of the material receipt, testing and disposition process, they will be expected resolve complex issues, triage issues for escalation to Lead Specialists and train junior staff members. They will provide input on issues within their area of responsibility to Lead Specialists or management for resolution and/or improvements. 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 general coaching and will be expected to be well-versed with established workflows and the associated policies.
Responsibilities
- Independent review of material documents and interact with internal customers for disposition of materials.
- Participation in Technology Transfers
- Reviewing, revising and approving various material specific documents
- Training Juniopr Support Staff
- Perform other duties as assigned.
Key Requirements:
- High School Diploma, Bachelor’s Degree preferred.
- 5-10 years of GMP experience
- Experience iGMP environment preferred. Biotechnology manufacturing background is preferred.
- Knowledge of GMP’s and regulations
- Experience with Trackwise, SAP, Syncade and Microsoft Suite preferred
- Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities, attention to detail, works effectively individually and with teams
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.