Professional Experience
DHL/Exel Supply Chain (2010-Present) Mechanicsburg, PA
Quality Manager (2011-present):
• Manage multiple pharmaceutical and clinical trials quality systems.
o Implement best practices and process standardization for network and global customers.
• Ensure sites comply with US and EU GxP standards.
• Developed and now lead the Risk Management Program (ICH Q9) for clinical activities.
• Responsible for the assessment and management of GMP critical suppliers.
• Provide quality oversight in site CIP projects.
• Oversight of change management for facility, process, and system validation (GAMP 5).
• New Business - Perform risk assessment based on product mix. Ensure alignment with current contractual obligations and identify gaps in regulatory requirements.
• Responsible for managing salary direct reports.
Quality Assurance Coordinator (2010-2011):
• Planned and coordinated quality management systems for multiple life science and clinical trial accounts including cold chain activities:
o Led change control process for facilities including the evaluation and mitigation of risk.
o Worked with operations on performance and continuous improvement teams.
o Managed CAPA programs for multiple clients.
• Managed GMP repackage /relabeling activities on site.
• Managed licensing for the distribution and storage of goods.
Glatfelter (2001-2006) Spring Grove, PA
Product Assurance Engineer (2004-2006):
• Managed product and service relationships with customers:
o Customer liaison throughout products life cycle (development phase to standard production).
o Performed root cause analysis and implemented corrective actions in manufacturing processes linked to customer complaints.
o Identified trends in product quality and implemented the processes changes required to correct.
o Chaired customer quality review meetings.
• Negotiated Job Lot sales for Engineered Products (volume of 400 tpm).
• Performed annual inventor...
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