Barbara Gibson

• Reduced scrap and testing required, achieving $500K in savings and improving efficiency by creating process optimizations.

• Prioritized and eliminated process losses by leading technical teams in conducting root cause analysis.

• Met project requirements and regulatory standards by developing documentation, diagrams and specifications.

• Interviewed and trained 3 new Process Engineers, accommodating workload and replacing roles lost to attrition.

• Improved quality and reduced production errors by implementing lifecycle changes for Solids Oral Dosage forms and Dry Powder Inhalers.

• Reduced batch throughput time by learning and utilizing Rockwell’s Electronic Batch Record PMX and Pharmasuite.

• Provided technical assistance to production team when issues arose, recommending compliant path forward.

• Mentored and developed new Process Engineers to promotion, furthering careers within organization.

• Investigated non-conformance issues / deviations, writing investigation reports and identifying CAPA.

• Identified root cause and CAPA by facilitating cross-functional technical teams.

• Managed intake by supervising specialists and approving complaints.

• Reviewed and approved Annual Product Reviews (APR), meeting FDA requirements.

• Communicated consistency problems and production deficiencies by providing regular updates to team leadership on quality metrics.

• Achieved quality product by directing work of Quality Supervisor and Quality Technicians.

• Maintained design specification documentation of bottles produced, providing valuable manufacturing reference.

• Evaluated, purchased and implemented testing software, tracking “in-process check” (IPC) data.