Drawing on a proven Quality Management System that has been built over decades to support drugs, biologics, medical devices and combination products, Lifecore has a strong, 40+ year global regulatory track record.
We recently spoke with Jessica Raddatz Hensley, Director of Quality Control (QC) who explained the work that QC scientists do, the technological advancements likely to impact this, and the common misconception people have about QC labs.
Jessica has almost 20 years of industry experience, having worked at other CDMOs before moving to Lifecore 12 years ago. At Lifecore, she has held various roles in analytical development and method validation before moving to her current role overseeing the QC function.
What work is undertaken in a QC lab? What is the ideal skill set for a QC scientist?
We conduct microbiological, chemical, and physical tests to ensure that finished product batches meet their quality requirements and are safe to be released to patients. We are also responsible for monitoring our cleanrooms and our water supply for contamination that could affect products Lifecore is manufacturing.
We perform validation work too, supporting our partners who are in the early stages of drug development by creating or validating their panel of tests. We also offer stability programs, monitoring product throughout shelf life to ensure it maintains quality.
In terms of key skills, critical thinking and problem-solving are top priorities. Attention to detail and relevant education are essential, but the ability to ‘figure things out’ sets candidates apart.
Are there any misconceptions about QC?
Common misconceptions are that the work is not very exciting, or that there is little scope to try something new because things are very routine. In fact, the dynamic nature of working in a CDMO and having exposure to many partners and products means there are significant opportunities for continuous improvement, which is very satisfying. Having the opportunity to evaluate what you’re doing over time and to be creative in looking for ways to be better is exciting.
There is also a lot of troubleshooting and problem-solving work which is challenging…but enjoyable. It’s very rewarding coming to work every day with the knowledge that you are helping to make sure that patients have safe treatments and medicines.
How does quality extend beyond the QC lab at Lifecore?
A few years ago, we implemented a new process in which the Manufacturing teams conduct some of their own quality checks for buffers and bulk material. This change has increased efficiency because the Manufacturing teams no longer need to wait for QC, and it also minimizes risk because it reduces the passing of materials between teams and areas.
Of course, QC is responsible for releasing batches, but that doesn’t mean that Manufacturing cannot do their own quality check– and they do a great job of it. We can all have a ‘quality mindset’.
What technological advancements in QC work excite you the most right now?
I’m interested in what AI can do for us. There are obvious limitations in that we are subject to various regulatory rules. But outside of GMP processes, for example in trending and reporting, AI tools will save us a lot of time.
Another area I’m excited about is rapid microbiology methodologies, because historically, that’s the slowest process. We can’t make microbes grow faster in the sterility test, but there are now technologies that can speed up that testing. Ultimately, these technologies aren’t just about speed, but ensuring patients receive safe, high-quality therapies sooner.