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 are seeking an experienced Quality Assurance professional with management experience to join the Bioscience team in Walkersville, MD. You will be working in a fast-paced, highly regulated environment with a fabulous group of QA team members on the LAL (Limulus Amebocyte Lysate) team. Additionally, you will be responsible for overseeing and directing all aspects of quality assurance and compliance with applicable regulatory requirements for media related products. The ideal person for this role will have experience in aseptic filling of biologics, through knowledge of FDA regulations and will be a strong collaborator/leader with excellent communication skills.
See what we are all about: Lonza Bioscience | Lonza
Key responsibilities:
- Directs staff of QA operations specialists that review and approve device master records, batch records, testing, and aseptic operations.
- Managing QA team to comply with internal requirements, applicable FDA regulations including ISO and 21CFR820.
- Participate in the development of actions plans to correct deficiencies and improve processes and provide direction for complex deviations and complain investigations.
- Leads/supports regulatory or client audits as SME for LAL (Limulus Amebocyte Lysate) team.
- Develop and approve cGMP documents, ensuring process efficiency.
- Maintenance of quality systems and cGMP compliance for the business
To apply for this job please visit www.lonza.com.