Colin Ewing

Review customer documentation to assess required validation activites

Investigate and resolve validation deviations and errors with QA and department managers

Manage validation documentation in compliance with SOPs and GMP standards

Maintain database and ensure timely PM's and calibrations

Assist Quality Systems, Product Management and Operations teams

• Responsible for managing 100+ vendors and keeping accounts current and aligning with supplier records
• Proficient with Microsoft Office, Coupa, and Accuterm software.
• Assisted with: Invoicing issues, Outstanding credits, Payment concerns, etc.
• Reviewed and price-checked invoices prior to submitting for payment approval. Processing invoices in a timely manner to align with current terms.

• USP Water Sampling
• 3M, P&G, J&J Customer Audits
• FDA Audits
• QA Review of all batch documentation to insure accuracy
• Forklift Certification
• SOP's
• Inventory control of USP Water System
• Order Filters, sanitization chemicals, UV Lamps. Resin tanks etc.
• Batch Prep
• Bulk Manufacturing orders
• Log book audits
• Maintain & Sanitize equipment before and after batch processing
• Light Mechanical/Check change pumps.mills.and TriBlenders