Shannon Nicholas
Quality Sr. Specialist with 10 years in a cGMP environment in the Pharmaceutical/Biotech Industries
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About
I’m a Quality and Compliance professional with a strong background in biotechnology and life sciences. I’m passionate about problem-solving, continuous improvement, and helping teams build effective, compliant processes. Known for being detail-oriented, adaptable, and supportive, I enjoy creating positive working relationships and thriving in fast-paced environments. I bring a strong work ethic, a collaborative mindset, and a genuine passion for growth and helping others succeed.
Experience
- 10+ years of experience in FDA-regulated pharmaceutical, biotechnology, and GMP manufacturing environments specializing in CAPA remediation, investigation leadership, and Quality System improvements (21CFR 810).
Industries: Biotech | Pharmaceutical | Food Manufacturing | Clinical Manufacturing
- Recognized for strengthening CAPA programs by coaching investigation owners, improving root cause analysis quality, and implementing sustainable corrective actions.
- Extensive experience supporting regulatory readiness, QMS improvements, and cross-functional remediation initiatives in roles such as a QMS Remediation Lead, CAPA SME and Investigation Coach.
- Strategic PMP skillsets utilizing leadership and organizational methodologies to achieve compliance. Driven to motivate professionals across interdisciplinary teams to realize outcomes of the highest integrity.
Education
I have a B.S. in Microbiology/Biotechnology from Delaware Valley University in May 2008.
I am pursuing a Biotechnology of Project Management from the University of Washington beginning August 2026.
