Esther Olivarez

• Coordinated with Metrology department to track and ensure timely calibration and maintenance of critical production assets and instruments, maintaining 100% compliance with calibration schedules and GMP requirements to support accurate manufacturing processes and prevent equipment-related deviations.

• Partnered with Quality Assurance team to verify proper completion and review of logbooks, data sheets, and batch records, ensuring accurate, timely documentation in alignment with FDA regulations, SOPs, and data integrity standards.

• Utilized SAP system to confirm material availability, verify solution preparations, and reconcile inventory

within active production batches, ensuring correct lot usage, and supporting accurate batch traceability.

• Assisted in the preparation, documentation, and follow-up of product incident reports, supporting root cause analysis, impact assessments, and regulatory compliance.

• Performed in-process quality inspections of IV bags throughout the production line, visually assessing for defects such as leaks, damaged overwrap, particulate matter, or seal integrity to ensure compliance with strict GMP and product specifications.

• Collected and documented representative samples at designated intervals during manufacturing batches, accurately recording observations, measurements, and test results in batch records and electronic systems to support traceability and release decisions.

• Maintained detailed, accurate documentation of inspection findings, sampling data, and process checks in compliance with FDA regulations and company GMP requirements, supporting successful internal audits and regulatory inspections.

• Supported continuous quality improvement by escalating potential issues (e.g., recurring defects or process variations) and assisting in root cause investigations to reduce defects and enhance overall product reliability.

• Inspected and manually loaded IV bags into preassembled boxes while ensuring product integrity, identifying and removing any leakers or bags with damaged overwrap to maintain strict compliance with GMP standards and prevent contamination risks.

• Conducted thorough line clearances at the end of each batch, systematically inspecting the entire production line for dropped or residual bags to eliminate lot mix-ups and ensure 100% batch traceability and product purity.

• Performed visual quality checks on IV bags during packing process, verifying no defects in overwrapping or leaks, which supported zero-tolerance quality requirements in a sterile pharmaceutical environment.

• Collaborated with packing team to maintain efficient workflow, accurately loading and organizing bags to meet production targets while adhering to safety protocols.

• Contributed to batch documentation and compliance by confirming all bags from current lot were accounted for and properly packed, reducing potential for cross-contamination and supporting successful regulatory audits.

• Maintained clean and organized work area in accordance with pharmaceutical Good Manufacturing Practices (GMP), minimizing downtime and ensuring consistent product quality across high-volume shifts.