Catalino Mateo
Fitchburg,Ma
Summary
Accomplished Senior Quality Control Inspector at Vericel Corporation with expertise in cGMP compliance and supplier quality assurance. Proven track record in managing corrective actions and facilitating quality meetings, enhancing operational efficiency and compliance. Skilled in LIMS data analysis and effective vendor communication, driving continuous quality improvements in product processes.
Overview
8
8
years of professional experience
Work History
Senior Quality Control Inspector
Vericel Corporation
11.2016 - 11.2024
- Verified manufactured products for cGMP compliance through assay transfers, validation, and qualification of new instrumentation in quality control laboratory.
- Inspect Epicel lot release batch records for accuracy.
- Sample, inspect, and release or reject components and raw materials per SOPs and specifications.
- Inspect products and components per specifications and SOPs.
- Monitored LIMS for raw material operations and process flow to ensure compliance and efficiency.
- Managed the process of corrective actions for suppliers to ensure compliance and quality improvements.
- Supported the management of supplier change requests to ensure effective communication and compliance.
- Support ambient and cold chain control environment site oversight.
- Perform material qualification testing program activities.
- Support carbon dioxide identity assay (CO2).
- Coordinated with vendors and manufacturers to secure material documentation for FDA compliance and product processing.
- Host virtual meetings to discuss issues, non-compliance concerns, and process improvements.
Education
associate degree college - Biotechnology
Quinsigamond Community College
01-2027
IT Certificate/A+ Certified -
Lincoln Tech Institute
01-2012
Skills
- cGMP compliance
- cGMP batch record review
- Batch record review
- SOP management and updates
- Supplier Quality Assurance
- CAPA management
- Deviation management
- Risk assessment
- Material Qualification Testing Program
- LIMS Data Analysis
- Data Management Software
- Cleanroom management
- Vendor communication and coordination
- Facilitate Quality Meetings
- Supplier notification management
Timeline
Senior Quality Control Inspector
Vericel Corporation
11.2016 - 11.2024
associate degree college - Biotechnology
Quinsigamond Community College
IT Certificate/A+ Certified -
Lincoln Tech Institute