Natsuko Wise

Cleanroom Optimization Program — Project Lead

Reduced environmental monitoring workload by 50% and achieved ~40% cost savings.

• Led a full-cycle program involving Manufacturing, QA, and Facilities, and Regulatory.
• Built a project timeline with deliverables, owner assignments, and status checkpoints.
• Conducted technical feasibility assessments using historical data and JMP statistical modeling.
• Drove weekly stakeholder syncs and managed project risks.
• Delivered final executive report with validated trend data and implementation plan.

QC Testing & Review Centralization Program — Program Owner

Implemented a controlled QC tracking system via Smartsheet that resolved a key audit finding.

• Developed a centralized tracker with permission controls and automated status visibility.
• Defined workflow requirements, built documentation, and trained cross-functional groups.
• Created dashboards to monitor turnaround time, identify bottlenecks, and improve follow-through.
• Eliminated missing documentation errors and improved review cycle consistency.

Disinfectant Efficacy Study — Technical Program Lead

• Coordinated internal teams and external contract labs across a 4-month validation project.
• Defined scope, acceptance criteria, timelines, and sample matrices.
• Managed study logistics, risk assessments, and vendor deliverables.
• Consolidated data outputs into a final technical report for QA/Regulatory.

EMPQ Qualification Support — Cross-Site Contributor

• Coordinated timelines with Validation, System Owners, and Manufacturing.
• Managed documentation and ensured all reports met compliance and traceability requirements.

Additional Responsibilities

• Managed Agile eQMS workflows including CAPAs, deviations, investigations, and change controls.
• Created SOPs, risk assessments, and project documentation packages.
• Served as SME for the EM Program and provided data insights using JMP and Excel.
• Facilitated interdepartmental meetings, agenda planning, and action-item follow-up.
• Supported audit readiness and regulatory/quality inquiries.

• Coordinated R&D sequencing projects using structured experimental plans.
• Owned weekly performance dashboards and communicated trends to scientists and PMs.
• Used Bugzilla and JIRA for issue tracking and workflow documentation.
• Partnered with engineering and data teams to troubleshoot platform inconsistencies.