PATRICIA S. GANTERT

• Compliance professional with over ~30 years of progressive responsibility in the pharmaceutical/biomedical industry. Demonstrated ability to build professional rapport and interact effectively with internal and external clients.

Activities include the following:

• Educated employees on specific QA standards and specifications.
• Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies/deviations.
• Prepared quality and performance data to support operational decision-making.
• Performed standard first article inspections and random sampling inspections to verify adherence to regulatory standards.
• Recorded findings of inspection process, collaborating with quality team to implement corrective actions where applicable.
• Conducted investigations into questionable test results related to raw materials receipt and release.

Highlights:

• Maintained document control system and updated work instructions, procedures and associated databases.
• Worked with internal staff to process documents and sent for closing.
• Collaborated across departments and levels of management to gain consensus on procedural documentation.
• Converted documents from one application to another.
• Created and maintained user accounts and properly routed documents for approval and training.
• Uploaded company procedures and policies to EDMS, routing for approval and training.