Ashley Hansen Email & Phone Number

Maine, United States

• Participate, help organize and contribute to new product development teams to deliver outstanding quality products to customers.
• Collaborate with business partners/stakeholders to assist with complex process challenges and aggressive timelines associated with launching new products.
• Lead projects, monitor activities, evaluate quality opportunities, and take initiative to drive improvement in quality assurance processes and develop quality culture.
• Situational agility and operates with a customer focus and with an analytical and innovative mindset.
• Manage escalated/critical issues, risks, deviations and assists teams with the quality management system.
• Provide coaching and guidance to business partner/stakeholders to assist in developing and strengthening quality mindset.

Westbrook, Maine, United States

• Creates well-written and accurate documentation, in support of R&D and manufacturing activities.
• Supports teams to obtain knowledge from R&D processes and transfer into production/manufacturing.
• Collaborates with teams to obtain an understanding of the product and documentation requirements.
• Ensures that documents are produced in a timely and efficient manner, adhering to established processes.
• Creates and manages the device master record and change orders for each project.
• Tracks project documentation schedules, reports on progress and takes corrective action as needed.

Westbrook, Maine

• Work between R&D and production Bioprocess to help transfer/train on new processes.
• Work with small and large-scale antibody/cell culture production.
• Aseptic technique
• Hybridoma cell growth
• mammalian cell culture
• hollow fiber systems

Bachelor’S Degree, Biology, General

Associate’S Degree, Veterinary/Animal Health Technology/Technician And Veterinary Assistant, 3.8

Maine State License

Associate’S Degree, Liberal Arts And Sciences/Liberal Studies, 3.8