EDWIN GARCIA FLORES
Summary
Detail-oriented Quality Specialist with 11 years in pharmaceutical manufacturing and regulated environments. Expertise in operations quality, batch record review, audits, and FDA/CGMP compliance. Proven ability to enhance product quality and support manufacturing processes while driving continuous improvement through Lean Six Sigma methodologies.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Batch Record Review Specialist
Merck
01.2021 - 10.2025
- Executed review, audit, and approval of manufacturing batch records for compliance with written procedures and cGMP requirements.
- Managed issuance of controlled documents, upholding compliance with regulatory standards.
- Managed high and medium critical forms to ensure accuracy and completeness.
- Issued manufacturing records and forms, ensuring accurate production documentation.
- Collaborated with cross-functional teams to uphold quality assurance processes.
- Coordinated audits and inspections to ensure adherence to operational integrity.
- Conducted troubleshooting activities, problem-solving, and root cause analysis for operational improvements.
- Analyzed data to identify trends and potential areas of improvement.
Integrated Process Technician – Control Substances
Merck
12.2018 - 12.2020
- Executed extrusion, granulation, coating, and blending functions to ensure adherence to SOP and GMP standards.
- Monitored processes to uphold product quality and compliance with industry standards.
- Supported facility and equipment qualification and commissioning to optimize operational readiness.
- Collaborated with teams to troubleshoot and resolve equipment issues.
- Disassembled, cleaned, inspected, and reassembled manufacturing equipment per standard operating procedures.
- Managed inventory system transactions to ensure accurate records.
- Trained new employees on safe work practices within the plant environment as well as machine operation techniques.
Quality Control Integrated Process
Merck- Apple One
08.2017 - 12.2018
- Provided on-floor support to manufacturing operations, ensuring quality standards were met.
- Evaluated and classified foreign materials for compliance with regulations.
- Documented deviations and non-conformances to support continuous improvement efforts.
- Participated in problem-solving initiatives, assessing manufacturing quality issues.
- Inspected and approved cleanliness of equipment and manufacturing areas.
- Generated and evaluated shutdown certification forms to ensure compliance and operational continuity.
- Reviewed and approved EMS/BMS alarms to maintain operational integrity.
- Identified and proposed improvements for manufacturing and packaging processes to enhance overall quality.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
Quality Specialist Shop floor
McNeil Healthcare, LLC
12.2013 - 09.2016
- Ensured quality and compliance across all operational actions.
- Reviewed production batch records and documentation to ensure accurate lot release.
- Led site audits to maintain regulatory standards.
- Conducted periodic walkthroughs of operations and warehouse areas to verify GMP compliance and optimal room conditions.
- Performed in-process audits according to established procedures.
- Trained staff on quality assurance practices and regulatory requirements to enhance compliance understanding.
- Monitored production processes to identify areas for continuous improvement.
- Implemented corrective actions to address non-conformities effectively.
Quality System Specialists/Annual Product Review
McNeil Healthcare, LLC
03.2012 - 12.2013
- Compiled product data for review, encompassing manufacturing batches and laboratory investigations to ensure compliance and quality standards.
- Analyzed in-process test results from all batches manufactured, focusing on weight, dimension, friability, and hardness.
- Utilized control charts and process capability studies for detailed data analysis.
- Conducted trend analysis on non-conformance issues, identifying root causes and recommending actionable continuous improvement plans.
- Automated job functions to enhance efficiency across operations.
- Collaborated with departments to integrate quality into processes and systems proactively.
- Participated in investigations of non-conformance events to identify root causes.
- Implemented key process improvements, optimizing systems to enhance operational efficiencies and streamline quality assurance.
Quality Assurance Technician
McNeil Healthcare, LLC
09.2011 - 03.2012
- Provided written and objective evidence to establish compliance of components, processes, and products with established procedures and Good Manufacturing Practices through sampling, inspection, audits, analysis, and approval.
- Generated non-conformance reports to identify and address quality issues, facilitating corrective actions.
- Participated in internal audits to maintain regulatory compliance standards.
- Reviewed, analyzed, and evaluated packaging record data to ensure compliance with internal controls and good manufacturing record processes.
- Trained new staff on quality assurance processes to enhance team competency and adherence to standards.
- Conducted statistical sampling of the production.
- Perform inspections of the product in the packaging lines during the validation process and special projects.
Education
MBA - Quality Management, Finance Management
BBA - Operations Management
Skills
- Quality assurance
- Document management
- Data analysis
- Data interpretation
- Trend analysis
- Performance analysis
- Cost efficiency
- Time management
- Team leadership
- Adaptability
- Teamwork and inclusion
Certification
• Train the Trainer
• Yellow belt
• Lean Certification
• American Society of Quality - #6512459 CQA, ASQ Seminar, Business Excellence Consulting Inc.
• Yellow belt
• Lean Certification
• American Society of Quality - #6512459 CQA, ASQ Seminar, Business Excellence Consulting Inc.
Projects
- Cycle Time Reduce: Improve RFT of clearance at 60% Packaging Department
- Daily Walkthrough Metric Project
- Optel Vision Validation Line 31 and 10
- Cleaning Validations (Manufacture and Packaging)
- Process Confirmation Controls in Packaging Department (TAR, ERG, AbbVie Launch)
It Systems
- MIDAS
- QualityDocs (Veeva)
- SAP
- LSR
- Trackwise
- PI (Process Book)
- Environmental Monitoring System (EMS)
- ETQ
- Minitab 16
- Stat Graphic
- Compliance Wire
- PAS-X
- Maximo
- Cispro
- On-Demand
- E-Log
Timeline
Batch Record Review Specialist
Merck
01.2021 - 10.2025
Integrated Process Technician – Control Substances
Merck
12.2018 - 12.2020
Quality Control Integrated Process
Merck- Apple One
08.2017 - 12.2018
Quality Specialist Shop floor
McNeil Healthcare, LLC
12.2013 - 09.2016
Quality System Specialists/Annual Product Review
McNeil Healthcare, LLC
03.2012 - 12.2013
Quality Assurance Technician
McNeil Healthcare, LLC
09.2011 - 03.2012