Rachel Depa Email & Phone Number

Copenhagen, DK

Bothell, WA, US

• Manage all aspects of IT infrastructure and application implementation related projects
• Lead project teams and/or work-streams
• Utilize sound project management and SDLC methodologies
• Ability to work in a matrix managed environment where many resources are embedded part time on a particular team
• Develop and manage project intake process and resource capacity planning
• Escalate issues early and provide concise issue descriptions to upper level management coupled with recommended paths for resolution

Seattle, WA, US

• Mentor manufacturing compliance staff
• Drive improvement of the technical capabilities and quality practices within thedepartment
• Coordinate activities and resolve issues across the department, other groups, and/orprojects
• Respond to and/or resolve recurring technical or processing issues
• Develop and implement novel approaches to solving non-routine technical problems
• Own metrics related to manufacturing compliance

Bothell, WA, US

• Interface with internal and external auditors to coordinate site inspections
• Act as Backroom Manager during Client and Regulatory Inspections
• Enter observations of inspection into the site Quality System
• Confirm assignments/due date and promotes communication to ensure timely response of audit observation. Schedule and lead forums to ensure progress of audit response
• Finalize responses into the site Quality System, coordinate signatures on response, and send to Client as applicable
• Confirm CAPA is opened into the site Quality System open and tied to audit finding

Bothell, WA, US

During this time I will design and provide program structures for implementation cross functional departments, to ensure and support compliance adherence.

Bothell, WA, US

• Support the implementation of new processes in close collaboration with Program Managers, Process Transfer/Process Development, Engineering, and Validation team
• Provide support to manufacturing staff for new equipment and processes.
• Ensure process optimization and continuous improvement.
• Identify new technology for new/current assets and assist with identifying user requirements, procurement, and implementation as needed.
• Collaborate with engineering and validation teams to implement and qualify new equipment and controls.
• Author and update quality documents, such as Standard Operating Procedures (SOPS) and other technical procedures.

Chattanooga, Tennessee, US

Chattanooga, Tennessee, US

» Spearheaded relevant project teams through organizing meetings, schedule coordination, work statements management, budget control, SOP generation, as well as administering updates and changes to scope and work statements» Meticulously organized quality control documents and technical reports using various word processing and analysis programs» Devised.

Chattanooga, Tennessee, US

» Generated and controlled all quality system and manufacturing documentation including bill of materials and related documents» Project leader for design control regarding medical device development, with additional contributions as the quality reviewerfor the team and resource for assurance of standards compliance throughout implementation» Sustained and.

Chattanooga, Tennessee, US

• Responsible for orders of supplies or request for services, and ensuring receipt prior to date of need.
• Responsible for reporting and communicating on a daily basis with Facility Personnel to facilitate activities aligning with QAD and QAS direction and objectives.
• Ensures that all executive management team and QAD are aware of all critical issues.
• Responsible for receiving/preparing purchase orders, invoices, and/or pack slips for the distributors.
• Responsible for managing controlled inventory and records.
• May review donor file record contents.

Chattanooga, Tennessee, US

• Prepares Quality Procedures.
• Reviews form entries and verifies completion of all paperwork.
• Inspects products, complete forms, and quality records for compliance with Seed Biotech, Inc. requirements.
• Assists with tracking, tracing and inventory management of tissue for transplantation from receipt to post distribution.
• Conducts audits as requested.
• Prepares reports as requested

• Authored Quality Assurance specifications and production documents for animal tissue material based medical devices.
• Conducted Internal audits of facility systems and ensured compliance with all in-house and mandated regulation.