Quality isn’t something you test into a product—it must be built in from the very beginning. I encourage people to imagine the product going into themselves or someone they love. That mindset shifts how you approach every task. It reminds you that no matter what your title is, you play a direct and essential role in product quality for protecting patients’ safety.
Quality to the Core: A Conversation with Melissa Seaver
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 Melissa Seaver, Director of Fermentation, Sanitization, and Manufacturing Compliance. With nearly 29 years at Lifecore, Melissa offers a ground-level view of how quality is embedded across manufacturing lifecycle—from the moment materials arrive to the satisfaction of the customers who rely on the products Lifecore manufactures.
How does quality intersect with your role?
Quality really is at the heart of everything we do. It shows up in every team, every role, and every step to make a product that’s safe and effective for the people who depend on it. With so many teams involved in manufacturing, we make sure everyone understands the quality expectations for their part of the process. Over time, our process improvements have helped us put strong controls in place—from pre-production all the way through distribution.
In manufacturing, we rely on our partners in Quality Control and Quality Assurance every single day. They help ensure raw materials meet standards, equipment is properly qualified, and our cleanrooms and instruments are maintained and sanitized the way they need to be. In-process testing keeps us confident that processes run consistently and within the ranges we expect. And our Compliance team plays a key role by making sure batch records—one of the most important parts of the product—are accurate, clear, and follow good documentation practices (GDP). This gives our customers confidence when they review records throughout the product’s shelf life.
So yes—quality is woven into my role like a connecting thread. It guides my responsibilities and links my team’s work with the efforts of so many others. Even though my title isn’t part of the formal Quality organization, I’ve always believed that quality has to be built into the product from the very beginning, not checked in at the end.
Clean room training is a big focus for you. What does readiness look like at Lifecore?
Training is foundational. New employees begin with temporary clean room access, where they learn how a clean room works—laminar airflow, how to move deliberately, and how small actions can disrupt air flow. From there they gown with a trained technician and start in lower-classification areas like ISO 8 and ISO 7. They train and practice gowning in our Learning Lab before attempting qualification trials.
Our virtual reality training simulator has been a game changer. It simulates working in a clean room and displays invisible contamination risks while learning from errors in a safe environment. The trainee also receives objective, real-time feedback.
To qualify for higher-classification areas, they must successfully complete personnel monitoring—plating 18 distinct areas during a full gowning and passing three consecutive times. We also require a media manipulation exercise that demonstrates aseptic technique: transferring sterile media into test tubes and incubating to confirm no growth. It is a rigorous, skills-based approach designed to build habits that protect patients.
How do you ensure the team stays compliant?
I stay closely connected with our Quality and Regulatory teams. When requirements change, we update procedures and training, meet with impacted groups, and reinforce expectations. We also use a batch-record review matrix to trend what reviewers are finding. That helps us pinpoint whether we have an unclear instruction in a record, a training gap, or an individual who needs extra coaching.
Sometimes the fix is straightforward—like improving penmanship, documenting times correctly, or practicing the right way to apply GDP corrections. Other times we revise records that are confusing or hard to follow. We review the matrix on a regular cadence and adjust accordingly.
You also oversee site sanitization. How does that connect to quality?
Sanitization is fundamental to our operations. My team maintains cleanliness across both controlled and uncontrolled areas, including the aseptic filling suites. Effective cleaning and sanitization reduces cross-contamination risks and safeguard the environments where people and products interact and reinforce the consistent quality mindset expected throughout our facilities.
What advice would you give to someone interested in quality or supporting quality?