Project Coordinator I

Project Coordinator

The Project Coordinator I will support the industrialization, process improvement, or maintenance activities of new and existing programs, products, or processes at BioFire Defense. Project Coordinators will perform responsibilities within the parameters of the BioFire Defense QMS (Quality Managed System) to confirm that documentation practices meet standards for regulated medical devices or other products. Responsibilities include contributions to project plan execution and documentation, provide input to project resources, timelines, and deliverables. Project Coordinators are expected to collaborate with R&D development team(s), project managers, QA, Regulatory, and Operations teams to assist with the development and implementation of design control documentation and applicable manufacturing procedures according to internal Standard Operating Procedures and applicable external regulations.

Essential Duties and Responsibilities:

• Perform all work in compliance with company policy and within the guidelines of BioFire Defense's Quality System.
• Participate in, or facilitate project meetings, and assist with the documentation of action items and key decisions.
• Contribute input in the process of drafting project proposals, design documents, schedules, presentations, and technical reviews.
• Generate manufacturing instruction documents and records.
• Work collaboratively with project managers, area managers, Regulatory and Quality team members, Operations teams, and project stakeholders.
• Actively engage in meetings, interactions with peers, and other key stakeholders to ensure projects are executed in a timely, effective, and efficient manner.
• Use project scheduling tools to help monitor and execute project timelines.
• Write, track, and manage change notices and change orders.
• Independently manage or be an active participant in small projects.
• Assist with CAPA and NCR investigations, and documentation updates.
• Ensure consistent practices throughout all phases of the project life cycle.

Qualifications:

• Preferred Bachelor's degree in a STEM or Business field.
• 2+ years of laboratory, engineering, or professional experience may be substituted for degree.
• Proficient in Microsoft Word and Excel.
• Technical writing experience preferred.
• Familiarity with GMP practices or Lean Manufacturing is preferred.
• May be required to obtain and maintain a DoD Personnel Security Clearance.

Work Environment: Office Setting