James Fantuzzo
BLOOMINGTON,IN
Overview
7
7
years of professional experience
Work History
Quality Specialist
Boston Scientific
08.2022 - Current
- Develop working knowledge of the processes on six multi-product manufacturing production lines for biliary & pancreatic stents as well as needles used for diagnostic and therapeutic indications.
- Spearhead investigations into emergent production quality issues and properly document through the non-conforming event prevention (NCEP) process and implement additional correction as warranted.
- Interface with core team on a daily basis to assess priorities and action items as it is related to quality, scrap, and efficiency metrics.
- Presented manufacturing lines to the internal audit team and answered any questions regarding compliance and use of medical device.
Quality Assurance Representative - Supply Chain
Catalent Pharmaceuticals
05.2021 - 06.2022
- Manage supplier complaints and follow-up actions within agreed upon timelines.
- Review effectiveness of corrective actions.
- Notify suppliers of nonconformances identified in Incoming Quality Control.
- Keep track of open Supplier Complaint Records through TrackWise and ensure records are completed on time.
Assembler/Chemical Coordinator/Trainer
Cook Medical
05.2017 - 04.2021
- Assemble medical devices by adhering to written specifications, manufacturing instructions, and GMP.
- Ensure chemicals are handled properly (expiration dates, labeling, initial sets) and check inventory regularly.
- Visually inspect the work of trainees to ensure quality.
Education
Certificate in Regulatory Affairs
Ivy Tech Community College of Indiana
Bloomington, IN12.2017
Bachelor of Arts - History
Indiana University Bloomington
Bloomington, IN12.2014
Skills
- GMP
- Supplier Complaints
- Quality Investigations
- JDE
- SAP
- Corrective Actions
- Internal Audits
- Working/communicating with other departments
Timeline
Quality Specialist
Boston Scientific
08.2022 - Current
Quality Assurance Representative - Supply Chain
Catalent Pharmaceuticals
05.2021 - 06.2022
Assembler/Chemical Coordinator/Trainer
Cook Medical
05.2017 - 04.2021
Certificate in Regulatory Affairs
Ivy Tech Community College of Indiana
Bachelor of Arts - History
Indiana University Bloomington