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Riverhead
Grace Keller

Grace Keller

Quality Assurance Specialist

Pharmaceutical / Bio-tech

Riverhead, Town of Riverhead, Suffolk

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About Grace Keller:

With 6 years in sterile pharmaceutical environments, I blend deep microbiology expertise with sharp regulatory instincts and a love for quality systems that actually work. From aseptic filling simulations and stability studies to audit prep and deviation triage, I bring precision to chaos and compliance to complexity. Armed with a BS in Chemistry and currently leveling up with an MS in Project Management, I live for work that’s both meaningful and meticulously run. If it involves data, strategy, or cross-team problem-solving—count me in. Let’s build quality without compromise.

Experience

I’ve spent the past six years immersed in GMP-regulated environments, specializing in sterile manufacturing, microbiology, and regulatory compliance. I’ve led aseptic filling simulations, managed long-term stability programs, and handled complex deviation investigations—all while maintaining alignment with FDA requirements and audit expectations. I hold a BS in Chemistry and am currently pursuing an MS in Project Management, which allows me to pair scientific rigor with strategic insight. My strength lies in turning complicated data and workflows into actionable, compliant solutions—and fostering cross-departmental collaboration to keep quality systems running smoothly and sustainably.

Education

My BS in Chemistry from St. Joseph's College (Graduated 2020) laid the groundwork for a career rooted in scientific precision and analytical rigor. It equipped me with a deep understanding of chemical processes, laboratory techniques, and the regulatory frameworks that underpin pharmaceutical quality systems—especially within sterile manufacturing and microbiology.

Currently, I’m building on that foundation with an MS in Project Management from SNHU, which sharpens my ability to lead cross-functional teams, manage complex timelines, and drive strategic initiatives in regulated environments. This program complements my QA expertise by strengthening my skills in risk assessment, stakeholder communication, cost modeling, and continuous improvement. Together, these degrees help me bridge scientific know-how with operational leadership—creating quality strategies that are both compliant and scalable.

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