Nicholas N.

Operations Systems & Process Consultant | GMP - SOPs, Deviation & CAPA

I help clients turn complex workflows into clear, executable, and audit-ready systems. This includes system building, project management, SOP development, process documentation and workflow mapping for both regulated and non-regulated environments. I’ve spent 7 years starting up pharmaceutical manufacturing facilities, building business processes and quality systems from the ground up, including SOP frameworks, deviation/CAPA/change management processes, and documentation that stands up to regulatory scrutiny. Outside of regulated environments, I’ve also built and operated fully remote, system-driven profitable business operations, reinforcing my ability to design processes that are compliant, scalable, and usable. Let's work together and build your business systems to meet your operational needs! **cGMP Expertise (21 CFR 11/210/211 and 21 CFR 111)** I specialize in building and supporting GMP systems for manufacturing operations from initial setup through audit readiness. From my time in startup cell therapy manufacturing environments, I helped develop and implement core GMP systems including batch records, SOP frameworks, training programs, and facility operations. My experience spans both manufacturing and quality systems, allowing me to support projects from a practical, execution-focused perspective. I can support: • Batch record and SOP development • Deviation and quality system support • GMP training program development (including aseptic operations) • Facility startup and operational workflows • MES and documentation system alignment For dietary supplement companies, I provide GMP support aligned with 21 CFR 111 and NSF/ANSI 455-2, including preparation for NSF/Eurofins certification and FDA inspection readiness. I’ve developed a structured GMP roadmap for dietary supplement manufacturing facilities that outlines required systems, SOPs, documentation, and hiring needs, all mapped directly to CFR and NSF requirements. This allows for efficient gap assessments and a clear path to GMP compliance for your facility. **A preview of this roadmap is attached to my profile.** If you’re building, scaling, or preparing for an GMP audit, I can help ensure your systems are both compliant and operationally effective. **Work preview attached to my profile** 1) User Onboarding Workflow Documentation and Video (SaaS Platform) • Translated a multi-step user registration and authentication process into clear, executable documentation as well as an accompanying video for a Help Center FAQ. • Structured workflows across desktop and mobile environments • Incorporated conditional paths and user decision points • Designed for usability by end users while maintaining system integrity requirements