Nathan Ouellet

• Provide quality oversight and approval of minor, major, and OOS/OOT deviation investigations, associated CAPAs, and effectiveness checks in Veeva QMS (additional experience with TrackWise), ensuring alignment with internal SOPs.
• Served as part of QA leadership in the audit backroom during an FDA inspection resulting in zero Form 483 observations and no quality findings.
• Led a 5S continuous improvement initiative to optimize the Executed Batch Record (EBR) correction and review process, eliminating bottlenecks and enabling proactive batch release preparation.
  Implemented weekly EBR check-ins, visual management tools, and escalation mechanisms to improve correction timeliness and oversight.
  Enabled QA to approve and sign off EBR review weeks ahead of the QTA release schedule, improving release readiness and operational efficiency.
• Led a Product Changeover (PCO) process improvement initiative, eliminating a significant EBR backlog and revising SOPs to improve compliance, data integrity, and throughput.
• Championed and implemented the QA GMP Walkthrough Training Program across both New England sites:

- Completely revised legacy SOPs to align with current practices and ICH guidelines.
- Designed GMP walkthrough observation forms and developed an observation tracking and trending tool to identify systemic issues.
- Trained personnel to become GMP walkthrough trainers, strengthening site-wide inspection readiness.

• Conduct batch record review and final batch disposition, ensuring documentation accuracy and regulatory compliance.
• Support internal and external audits by preparing documentation, reviewing historical audit responses, and presenting quality system topics as needed.
• Actively promote a culture of quality and safety through leadership of the S.C.O.R.E. (Stop, Confirm, Observe, Review, Execute) program.

• Led GMP manufacturing operations while maintaining strict compliance with FDA, cGMP, and environmental safety regulations.
• Increased batch output by 25% and production volume by 10% through optimization of staffing, equipment utilization, and workflow efficiency.
• Drove a strong quality culture, reducing deviation rates through proactive floor presence, daily checks, and step-to-completion practices.
• Authored and reviewed GMP documentation including batch records, deviations, SOPs, batch reports, and change controls.
• Coached and developed team members, improving retention and performance through structured feedback and career development planning.

• Led kilo-scale synthesis and purification of pharmaceutical compounds in a GMP-regulated environment.
• Authored deviation reports and partnered closely with QA to develop compliant CAPAs using 6M and 5-Why root cause analysis.
• Improved product yield through purification efficiency initiatives adopted into routine kilo operations.
• Generated client-facing technical updates and internal progress reports.