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.● Conduct audits, check the quality of work by teams in accordance with quality standards and compliance requirements, identifying appropriate process/practice changes where necessary.● Working knowledge of the 9 and 21 Code of Federal Regulations (CFR).

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.• Provides leadership on documents from initiation through the life of the project.• Coordinate's documentation creation/edit strategy activities with stakeholders and ensures effective communication within project team.• Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience.• Work/communicate with quality assurance, regulatory, supply chain, procurement, and compliance teams on projects to ensure alignment with USDA, company’s standards and regulations.

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 • Accurately document all production work under USDA regulation.

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