Melissa Johnson

Maintain and validate production, inventory, and material data in SAP and manufacturing systems, ensuring 100% data integrity compliance

• Perform batch record review, release, and approval in alignment with GMP standards

• Generate and analyze performance metrics and production reports to support operational decision-making

• Partner with production, finance, and scheduling teams to resolve discrepancies and improve data flow

• Train and onboard new team members; develop training materials and process documentation

• Support process improvement initiatives, including data accuracy and workflow optimization projects

Managed batch record lifecycle, ensuring completeness, accuracy, and compliance with GMP standards

• Investigated and resolved CAPAs, deviations, and data discrepancies

• Maintained documentation in SAP, LIMS, TrackWise, and MasterControl systems

• Supported audits by ensuring proper documentation control and data traceability

• Generated reports and dashboards to track quality and production metrics

Coordinated project schedules, resources, and documentation using MS Project and Smartsheet

• Monitored project progress and reported risks to senior leadership

• Facilitated communication between cross-functional teams and stakeholders

• Prepared meeting materials, tracked deliverables, and ensured project timelines were met

Managed sample lifecycle in LIMS, including accessioning, tracking, and storage

• Ensured compliance with cGMP and FDA regulations

• Coordinated sample shipments to external labs while maintaining chain of custody and cold chain integrity

• Scheduled QC testing and tracked turnaround times with internal and external stakeholders

• Performed data trending and analysis of laboratory results

Managed sample inventory and tracking using LIMS and EMR systems

• Processed biological samples including centrifugation, aliquoting, and storage

• Maintained chain of custody documentation and ensured regulatory compliance

• Coordinated with internal teams and external partners on sample logistics

Performed venipuncture and specimen collection for diagnostic testing

• Entered and verified patient/sample data in Cerner and EPIC systems

• Conducted quality control procedures and maintained lab equipment

• Supported high-volume hospital lab operations with strong accuracy and efficiency

Collected and processed laboratory specimens, ensuring accurate data entry in LIS systems

• Maintained compliance with safety and quality standards

• Trained new staff and supported lab operations in fast-paced environments