QA Lot Release Specialist
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 Quality Assurance Compliance Specialist interacts directly with Lonza’s internal customers for disposition of final bulk products and resolution of release issues. They will require regular coaching and will be expected to be familiar with established workflows and the associated policies. They will provide input on issues within their area of responsibility and escalation to Lead Specialists or management for resolution and/or improvements.
- Interact with internal and external customers for disposition of batches.
- Reviewing, revising and approving various product release documents.
- Participate in interdepartmental projects with specific guidance and instructions.
- Participate in routine meetings, data queries and report section compilation as assigned by management.
- Continuously develop review skill set which includes:
- understanding application and relationship of overall Quality System Elements (e.g. Change Control, CAPA, Deviation, Continuous Improvement, etc.) to update of procedures;
- effective communication;
- active listening and conflict resolution.
- Perform other duties as assigned.
- Associates with 1 year exposure to FDA or Agency GMP regulated environment; equivalent relevant experience may be considered
- Knowledge of GMP’s and regulations preferred (e.g. ICH Q7-Q11, CFR 210, 211, 600-680, 820, etc.).
- Excellent written and verbal communicator at all levels. Experience with Microsoft Office Tools (e.g. Word, Excel, Outlook, & PowerPoint) preferred.
- Experience in enterprise systems such as DMS, TrackWise, SAP, Syncade, etc. preferred.
- Motivated self-starter who has high attention to detail and adoptable to changing priorities and reprioritization of workload.
- Works effectively individually and within a team environment with direction as required.
- Presents facts clearly and logically and understands other perspectives.
- Able to identify and act on situations that require escalation with / without guidance.
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.ID:uDnQdo