Yanni Nacpil
Noblesville
Summary
Results-driven Quality Professional with expertise in product integrity and compliance. Proficient in identifying system inefficiencies, implementing quality control measures, and optimizing operational processes. Strong analytical skills and attention to detail drive continuous improvement initiatives.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist
Stevanato Group
04.2024 - Current
- Manage document control processes, ensuring proper creation, review, approval, distribution, and archival of quality records to comply with company policies, GDP, GMP, and ISO regulations.
- Oversee version control and document changes to maintain accuracy, consistency, and traceability, ensuring all revisions are properly documented.
- Train cross-functional teams and new hires on eQMS usage, document workflows, and best practices to ensure compliance and efficiency.
- Support external and internal audits by organizing required documentation, providing auditor access to records, and assisting with root cause investigations and implementation of corrective and preventive actions (CAPAs).
- Lead project process improvements like Process Mapping and Kaizen to optimize operational workflows, enhance traceability, and ensure regulatory compliance.
- Developed and implemented testing protocols to identify defects and improve overall product quality.
- Strong familiarity with ISO regulations such as ISO 13485, ISO 9001, ISO 15378. Certification obtained for ISO 19011.
Mitraclip Lead Specialist
Abbott
01.2022 - 01.2024
- Oversee day-to-day operations, ensuring daily tasks are performed efficiently and executed according to quality standards.
- Escalate any issues, concerns, or commendations from operators to Engineers or Supervisors.
- Perform lot reviews and data analysis using PowerBI, SharePoint, Citrix, Microsoft applications, and Teams.
- Ensure that the team successfully meets daily production targets.
- Provide support to other sub-assembly groups as needed.
- Order materials required for the production line.
- Enter data for training logs, downtime hours, outputs, and metrics.
- Manage projects for process improvements to enhance manufacturing practices.
- Enforce GDP and GMP compliance by ensuring that expectations are communicated to operators and procedures are followed.
- Maintain audit readiness and ensure ongoing compliance with regulatory requirements.
Kit Production Assistant II
Labcorp
01.2020 - 01.2022
- Streamlined assembly and shipping of protocol-specific kits and materials.
- Generated printed materials and pre-assembled components for efficient production.
- Maintained adequate supplies by replenishing assembly materials as needed.
- Supported production lines to consistently meet target objectives and goals.
Education
Bachelor's Degree - Health Sciences
Indiana University-Purdue University
01.2022
High School Diploma - undefined
Noblesville High School
01.2018
Skills
- Strong organizational and time-management skills
- Exceptional communication and interpersonal skills
- Ability to work independently and as part of a team
- Detail-oriented and able to handle multiple tasks simultaneously
- Experience in project management and meeting deadlines in a timely manner
- ISO 19011 certification
Certification
ISO 19011
Timeline
Quality Assurance Specialist
Stevanato Group
04.2024 - Current
Mitraclip Lead Specialist
Abbott
01.2022 - 01.2024
Kit Production Assistant II
Labcorp
01.2020 - 01.2022
High School Diploma - undefined
Noblesville High School
Bachelor's Degree - Health Sciences
Indiana University-Purdue University