Summary
Overview
Work History
Education
Timeline
Skills
OperationsManager

Cathy Marquez Vazquez

Kutztown,PA

Summary

Dedicated professional with a proven track record in cGMP-regulated environments, specializing in team leadership, operational efficiency, and quality assurance. Skilled in maintaining compliance with FDA standards, training employees, and driving process improvements to meet production goals. Known for building collaborative teams and ensuring high-quality outcomes in fast-paced manufacturing settings.

Overview

11
11
years of professional experience

Work History

Line Leader II - Pharmaceutical Packaging

Sharp Inc.
02.2023 - Current

• Lead daily production operations, ensuring safety, quality, and workflow targets are consistently met across multiple packaging processes.

• Provide real-time leadership to associates, coach PAII staff, and reinforce compliance with SOPs, cGMP, and safety expectations.

• Communicate cross-shift updates with previous LL, escalate issues to QA/Supervisors, and ensure smooth operational handoff.

• Review batch records, work orders, and Lot/Exp assignments for accuracy; identify errors, correct discrepancies, and report deviations promptly.

• Oversee and verify equipment challenges, daily checks, calibration reports, and cleaning activities to maintain audit-ready conditions.

• Troubleshoot equipment and process issues, make sound decisions to prevent delays, and coordinate with support teams to maintain production continuity.

• Train associates at the start of each shift, clearly explaining procedures, documenting sign-ins, and verifying job readiness.

• Maintain precise documentation of start/end times, downtime, reconciliation, and finished goods counts, ensuring alignment with BRR and cold storage.

• Conduct end-of-shift TOR verification, confirm normalization times, verify PAII recovery sign-off, and prepare all components/bulk for the next shift.

• Perform 200% checks when required, enforce proper PPE use, and routinely inspect the area to ensure a safe and compliant work environment.

• Collaborate with QA to maintain high-quality packaging standards, ensure accurate documentation, and support continuous improvement initiatives.

Quality Assurance Analyst

Stitch Fix
09.2015 - 08.2018
  • Performed detailed inspections to identify defects and ensure products met quality specifications.
    • Verified consistency, measurements, and overall integrity following established SOPs.
    • Documented findings accurately and communicated issues to cross-functional teams for timely resolution.
    • Supported quality investigations by reporting trends and contributing to root-cause discussions.
    • Maintained compliance with company quality standards and contributed to continuous-improvement efforts.

Production Line Leader

Kraft Food Dry Warehouse
11.2014 - 08.2015
  • Maintained a clean and compliant production area aligned with safety and quality standards.
  • Monitored line performance and identified issues affecting efficiency or product integrity.
  • Supported equipment inspections and preventive-maintenance tasks to reduce downtime.
  • Ensured team adherence to procedures and safe work practices.
  • Performed routine quality checks to verify products met established specifications.
  • Assisted in resolving team issues to maintain a productive and safe environment.

Education

Associate Of General Studies -

Colegio Educativo Lazaro
San Juan, Puerto Rico

Certificate - Cosmetology

NUC University
San Juan, Puerto Rico

Artes Culinarias -

NUC University
San Juan, Puerto Rico

Certificate - Quality Improvement in Healthcare Organizations.

Rutgers University
New Brunswick, New Jersey, NJ

Certificate - Operations Managements: Quality And Supply Chain

University of Illinois

Certificate - Lean Six Sigma Black Belt.

Six Sigma Online

Timeline

Line Leader II - Pharmaceutical Packaging

Sharp Inc.
02.2023 - Current

Quality Assurance Analyst

Stitch Fix
09.2015 - 08.2018

Production Line Leader

Kraft Food Dry Warehouse
11.2014 - 08.2015

Certificate - Lean Six Sigma Black Belt.

Six Sigma Online

Associate Of General Studies -

Colegio Educativo Lazaro

Certificate - Cosmetology

NUC University

Artes Culinarias -

NUC University

Certificate - Quality Improvement in Healthcare Organizations.

Rutgers University

Certificate - Operations Managements: Quality And Supply Chain

University of Illinois

Skills

  • Team Leadership & Coaching
  • Operational Excellence
  • Regulatory Compliance
  • Quality Standards
Cathy Marquez Vazquez