The Reagent Manufacturing Coordinator is role on the Reagent Manufacturing Project Management Team. The project coordinator will spend the majority of their time running Support Meetings for the Manufacturing work centers. The Reagent Manufacturing Project Manager will work in a collaborative manner with our manufacturing department leaders, project support team members, and subject matter experts to identify, prioritize, resource, and track improvement activities to completion.
Responsibilities include preparing for the support meetings agendas, facilitating meetings, creating meeting minutes and action plans, and completing other relevant tasks. Given that this is an entry-level role, the project coordinator spends a large portion of their time learning about the medical device setting, BioFire products, design control, change control, manufacturing processes, and risk management from project managers and support team members.
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Facilitates support meetings, presents topics, and coordinates meeting communication to align stakeholders and track goals/milestones
- Supports the development of group charters and goals in line with the manufacturing department’s needs and business objectives
- Assists support team members in requesting, scoping, resourcing, activating, prioritizing, and completing process improvements
- Assists support team members in drafting proposals, submitting, presenting, activating, prioritizing, and closing support projects
- Schedules meetings, create agendas, documents meeting minutes, correspondence, and presentations as needed
- Coordinates, prepares, presents, and communicates summaries of support meeting outcomes on a regular basis
- Works with project management to ensure change control, design control, and project management best practices are followed throughout the project lifecycle
- Leads process improvement projects in accordance with project management best practices
- Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
- Offers ideas for improving the support meeting structure and facilitates any changes to the structure and operating processes
- Takes an active role in learning about BioFire products, design control, risk management, and change control
- Promotes QSR and regulatory compliance into the support meeting related activities
Knowledge, Experience and Skills
- Bachelor’s degree in a related scientific or engineering field desired. No work experience is required with degree.
- 3+ years in a cGMP manufacturing environment with experience in coordinating improvement projects.
- Bachelor’s degree in a related scientific or engineering field 1+ years of work experience is required with a degree.
- In lieu of degree, 5+ years in a cGMP manufacturing environment with experience in coordinating improvement projects.
- Willingness and ability to interact effectively and harmoniously with other people at all levels within an organization
- Excellent communication skills, both oral and written
- Can effectively work as part of a team, and supports the team with a helpful attitude
- Proactive, self-motivated, and able to manage time effectively
- Critical listening skills, and an ability to recognize important and high-level information
- Organization and extreme attention to detail
- Ability to complete work quickly and efficiently
- Experience with MS Office including Word, Excel, and PowerPoint