mRNA Production Compliance Coordinator
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.
We have recently been confirmed as the global manufacturing partner for Moderna’s vaccine against the novel coronavirus, providing a tenfold manufacturing capacity increase. As other businesses face increasing economic uncertainty, we are fortunate to have opportunities for expansion. Through this new collaboration, our work will have a significant, direct and long-term impact on the management of this global pandemic.
We are looking for a Production Compliance Coordinator to join our manufacturing team for mRNA at Lonza Geleen. The mRNA Production Compliance Coordinator performs investigation of deviations and reports within agreed timelines. Defining appropriate Change Controls and CAPAs, and coordinates the implementation through the Production team to reduce the number of events and supports process improvement initiatives for Quality Issues.
- Initiation, review and revision of (executed) Batch records, SOPs, protocols, WI and other relevant GMP related documentation.
- Initiation, review and defining of appropriate Quality Events (deviation, Change Control and CAPA) and coordinates implementation, follow up and closure within agreed timelines and GMP regulations.
- Supports site wide quality improvements, process improvement and takes initiative in quality issues in conjunction with the wider organization .
- Able to fully adhere to preset plan as instructed by Manufacturing Team Lead, to identify potential issues impacting delivery and actively seek solutions in an independent manner
- Suggesting and implementing continuous improvement in regards to process, planning and training.
- Point of contact between departments, coordinates and support with the wider organization. Interacts constructively with other departments in the scope of his\her work.
- Supports consistent adherence to compliance through participation in Internal and external audits.
- Notification of supervisor of all observed observations/deviations in a timely manner with the ability to make constructive suggestions where appropriate and in line with cGMPs and local procedures.
- Bachelor degree in Science, Biotechnology or related discipline
- Accuracy, tidiness, well organized, problem solving, trouble shooting, result driven, attention to detail, flexibility. Strong planning, prioritization, and scheduling skills.
- Excellent understanding of GMP requirements and adherence to procedures.
- Strong planning and prioritization skills.
- Excellent problem solving skills. Pragmatic approach to change behavior or strategy based on new information.
- Strong ability to cooperate with other departmental managers.
- Excellent ability to communicate in both written and verbal format.
- Positive can do attitude, good listener.
- Able to effectively influence. Is flexible and adaptable to meet business needs. Timeliness in completing assigned tasks.
- Constructive interaction with other departments within the company.
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.