David Coles

Results oriented professional with 18+ years within a lean biopharma CDMO work environment, possessing a diverse cGMP/GDP background, strong desire, and proven track record of achieving continuous improvement in multiple disciplines within the business, aiming to leverage professional skills, knowledge, and years of experience to effectively gain the Operations Manager role within a prospective company.

Major Accomplishments

· Spear-headed capital improvement project to purchase, validate, and commission new equipment, including packaging vial labeler, vision system, laser coding units, and a vial leak detection unit. Facilitated design and layout of new packaging room and product vial inspection room and optimized cartoning machine to handle multiple product cartons to decrease work in process (WIP) and improve production throughput

· Drafted, implemented, and enhanced production and materials management operating procedures, including that for COVID-19 vaccine to improve personnel’s efficiency, attention to detail for each product’s specifications, and to improve first-time right performance, while reducing department-related CAPA’s

· One of two Training Administration Super Users responsible for transitioning site from paper-based training to Electronic Learning Management System, including development of site’s departmental training curricula and on- the-job training (OJT) qualifications, while maintaining system in audit ready state and driving Training KPI’s

· Recorded only one training and/or training system related audit observation at the site from 2013-2022

· Drafted and implemented Employee Onboarding, Status Change, and Exiting Procedure for the site, which included the creation of seven (7) facilitated new hire employee orientation/training system sessions

· Facilitated New Hire Orientation sessions for introduction to site’s Quality Management System and Learning Management System

· Implemented Train the Trainer Program at the site to enhance trainer requirements to meet industry standards

• Microsoft Word, Excel, & PowerPoint
• Pilgrim SmartSolve Quality Management System (QMS) (Administrator)
• TrackWise, QMS
• ComplianceWire Learning Management System (Administrator)
• Good Manufacturing Practices (GMP) Site Train the Trainer Program (Administrator)
• SAP/R3, Other Inventory Management Systems
• ISO 9001
• Kaizen
• 5S/6S