Quality Manager Jaana Putula, Ph.D, ensures the everyday quality-orientated precision of the DiagMMR test process
Jaana Putula is responsible for overseeing the quality management and compliance of the DiagMMR test at LS CancerDiag. She is involved in various stages of the DiagMMR testing and R&D process. Jaana completed her Ph.D. in cell signaling and has extensive experience in cell culture and other laboratory processes. Her expertise in these areas allows her to ensure careful handling of patient samples from sampling to testing with a quality-oriented perspective.
Jaana joined the LS CancerDiag team in 2017. She has a master’s degree in molecular biology and completed her dissertation in biochemistry. Jaana started her career at LS CancerDiag with laboratory work and has been working as a Quality Manager since 2018. Her daily tasks include planning, developing, and maintaining the quality management system. Jaana is the first person with her title in the company, which was created based on an identified internal need during the DiagMMR test validation work.
“During the validation of the test, we observed that it needs a responsible person dedicated to ensuring quality control throughout the testing process and regulatory compliancy. For commercializing the test, process monitoring is necessary, and it’s vital to maintain proper documentation and manage all records in a single system.”
Jaana finished her Ph.D. in 2014. After taking maternity leave, she switched from working at the University of Helsinki to LS CancerDiag. Although the work environment was similar to what she was used to, as the company had a university background, Jaana noticed some differences in goal-setting.
“At LS CancerDiag, the whole team works towards a shared objective. In academic research, you tend to focus on your research topics more independently, and in some ways, it can feel more isolated. Once a research project is completed, you move on to new projects. In commercial development work, the timeline is longer, and each individual research aspect contributes to achieving a broader goal. This creates a more comprehensive view of the entire process”
” I prefer working hands-on as it increases my motivation. Meeting patients is also a source of motivation for me. The results of my work have real meaning for them.”
Jaana has created LS CancerDiag’s electronic quality management system from scratch in her work. The QMS is currently being used by the company, especially in laboratory work. All standard operating procedures, work instructions, records, and product development projects, are stored in the quality management system. The system mainly serves as a storage system for the large number of documents required by medical device industry standards.
“Our operations require controlled and traceable document workflow as well as supplier and equipment management. Number of documents and records is so high that without our current quality management system, document handling would be overwhelming and prone to errors.”
Documentation updates are often required in connection with internal audits. In addition, the recent move to new laboratory premises has made it necessary to verify the documentation. Jaana is responsible for overseeing and coordinating the updating and reviewing of the documentation to ensure its accuracy. LS CancerDiag’s quality management system was certified in 2022. The certificate is valid for three years but requires annual surveillance audits by the certification body.
“Although a quality certificate is not necessary for product commercialization, adhering to the standard enhances a company’s credibility with investors and the scientific community.”
Jaana has discovered in her position that she would like to continue her career in quality management in the future. Although initially drifting to the position due to company’s needs, she has found that tasks requiring precision come naturally to her. Jaana finds motivation in working with real customer cases and meeting patients. Her encounter with the patient community became more tangible during the CGA-IGC Annual Meeting that took place in Las Vegas in October 2023, in which the LS CancerDiag team participated.
“The transition to quality management was natural for me. We couldn’t foresee the workload of implementing the quality management system and obtaining its certification, but I am not afraid of hard work. I prefer working hands-on as it increases my motivation. Meeting patients is also a source of motivation for me. The results of my work have real meaning for them. The Las Vegas conference was a memorable experience. Although the meeting was clinically focused and primarily attended by geneticists and gastroenterologists, the stories of patients with Lynch syndrome touched me the most.”