A Day in the Life…
Posted By admin / 26th Jun, 2020
…of Lifecycle’s Senior Director of Quality and Regulatory Affairs, Michelle Stahla-Quintana
The smell of coffee fills the air and white cups with a famous green mermaid sit on desks with a Post-It note adhered to each.
“Three things for a successful day,” it reads. “Laughter. Coffee. Glitter.”
The culprit behind this small token and major dose of motivation is Michelle Stahla-Quintana, Senior Director of Quality and Regulatory Affairs.
As Lifecycle Biotechnologies has grown and developed, so has Michelle. Beginning her career in 2008 as the Quality Supervisor with Chata Biosolutions, Michelle has since taken on many roles. In 2016, she was promoted to the Senior Director of Quality and Regulatory Affairs, a role she currently holds with Lifecycle Biotechnologies.
For Michelle, each day starts at 4:30am.
“Every morning the first thing I do is laugh as hard as I can,” Michelle said. “I find that it instantly puts a smile on my face even if my mood doesn’t match. I know that negativity can spread faster than [a] fire but I also know that smiles are infectious, and we are all humans.”
Known as the “sunshine” around the office, Michelle knows that quality comes along with high expectations and that’s not something to skimp on.
“Quality is assurance that you can trust the product is what you say it is,” responded Michelle when asked what “Quality” means to her.
Throughout the years, the changes made to the quality programs at Lifecycle Biotechnologies is tough to describe as the systems used to support our partners has completely transformed through continuous improvement and data analysis.
At its infancy, the quality management system was basic in that it included Standard Operating Procedures (SOPs), work instructions, batch records, partner specifications and a few log books. Today, Lifecycle’s quality system has grown to be built on a knowledgeable team that has successfully implemented a process for continuous improvement executing more than 75 change controls per year.
Additionally, the quality program today includes an electronic QMS system for documents, training, partner complaints, Non-Conformance Reports, Corrective Action Plans, preventative maintenance and calibration. This ensures traceability from cradle-to-grave.
With facilities certified to ISO 9001 and 13485, Lifecycle has also successfully maintained a registration with the FDA.
As for the future, Michelle sees “our programs going paperless where we are able to collect more data to enhance our partners and employees overall experience.” Some of these changes include real-time virtual monitoring of processes from beginning to end.
While many things have and will change with the quality programs at Lifecycle Biotechnologies, Michelle is also focused on continuous improvement.
“I have an internal motivation to be the best and develop others from knowledge I have gained,” Michelle expressed. “I don’t want to be a director. My goal is to be a leader that inspires others to be their best.”
Much of this inspiration comes from Michelle’s father who instilled in her a great work ethic and drive.
When asked for one thing she wishes partners knew about her, she responded “that we are an extension of them. We want to ensure we can support their goals by running systems that align.”
Allow Lifecycle and individuals like Michelle to be an extension of your staff. To learn more about our quality programs and how we can support your efforts, please feel free to chat or complete the form to the right or give us a call!