Miguel Antonio Alvarado De León
WINDSOR,ON
Summary
Industrial Engineer with 6+ years of experience in quality documentation, Quality Management Systems, and document control within a regulated pharmaceutical environment. Experienced in managing controlled documentation and records throughout their lifecycle, supporting audits, tracking corrective actions, and maintaining compliance with regulatory requirements. Experienced in using Microsoft 365, SharePoint, Excel, and Power BI to organize, manage, and report quality information. Detail-oriented and highly organized, with a proven ability to coordinate documentation activities, collaborate across teams, and identify opportunities to improve and streamline processes.
Overview
2
2
Languages
1
1
Certification
6
6
years of professional experience
Work History
Pharmaceutical Documentation Coordinator
Laboratorios Pharmedic
09.2019 - 08.2026
- Coordinate and maintain Quality Management System (QMS) documentation and records, ensuring information is accurate, current, properly controlled, and aligned with Good Manufacturing Practices (GMP).
- Manage the full document control lifecycle, including creation, review, approval, revision, issuance, distribution, obsolescence, and archiving, ensuring document integrity, traceability, and version control.
- Support internal and external audits by preparing and providing controlled documentation, maintaining audit records, following up on observations, and supporting corrective action tracking and closure.
- Maintain and organize electronic and physical quality records, ensuring controlled access, proper retention, and availability of current and approved documentation.
- Administer and improve SharePoint and Microsoft 365-based document management workflows, supporting the organization, accessibility, and control of quality information.
- Collect, organize, and analyze information from different departments to create and update procedures, operating manuals, job descriptions, and other controlled quality documentation.
- Provide training to new employees on GMP requirements, procedures, and documentation practices, supporting effective communication and implementation of process changes.
- Support continuous improvement of documentation processes by identifying opportunities to standardize, simplify, and optimize information workflows and document management activities.
Process Improvement Intern
The Central American Bottling Corporation
08.2019 - 09.2019
- Participated in a continuous improvement project applying the SMED (Single-Minute Exchange of Die) methodology to reduce changeover times on production lines.
- Analyzed and documented process changeover times, identifying opportunities to reduce downtime and improve operational efficiency.
- Supported the collection and analysis of time and motion data to identify process improvement opportunities.
Process Engineering Intern
Sherwin-Williams
09.2018 - 06.2019
- Analyzed and improved supply chain processes to prevent raw material stockouts and strengthen inventory control.
- Measured import lead times and identified raw material waiting times by developing visual reports and charts to track import cycles.
- Developed end-to-end process maps for planning and procurement activities to identify improvement opportunities and enhance process visibility.
- Supported the implementation of a raw material tracking module to improve monitoring throughout the supply chain.
Process Improvement Intern
ADOC, S.A. De C.V.
03.2018 - 07.2018
- Optimized production times and improved efficiency on the production line, reducing activity execution times by up to 25%.
- Supported process improvement initiatives focused on identifying opportunities to streamline production activities.
Education
Bachelor of Science in Industrial Engineering - Industrial Engineering
Universidad De El Salvador
El Salvador12-2021
Skills
- Document Control
- Document Review & Approval
- Standard Operating Procedures
- Document Management
- Good Manufacturing Practices
- Microsoft 365
- Microsoft Excel
- SharePoint
- Process Documentation
- Records Management
- Quality Systems
Languages
English
Professional Working
Spanish
Native or Bilingual
Certification
Internal Quality Auditor Training | INSAFORP, El Salvador | 2023
Timeline
Pharmaceutical Documentation Coordinator
Laboratorios Pharmedic
09.2019 - 08.2026
Process Improvement Intern
The Central American Bottling Corporation
08.2019 - 09.2019
Process Engineering Intern
Sherwin-Williams
09.2018 - 06.2019
Process Improvement Intern
ADOC, S.A. De C.V.
03.2018 - 07.2018
Bachelor of Science in Industrial Engineering - Industrial Engineering
Universidad De El Salvador