- Durham, North Carolina, United States
- On-site
- Full-time · Associate
- $79K–$125K per year
- 2+ years
The role supports the Durham manufacturing site by coordinating project activities, maintaining accurate project information, supporting change controls and incident writing, and helping teams complete actions to support PAI and filing.
Compensation
$79,200 - $124,700
Responsibilities
- Support Pre-Approval Inspection (PAI) and filing-readiness plans by tracking deliverables, owners, due dates, dependencies, and open actions
- Update readiness trackers and dashboards so milestones, risks, gaps, and recovery actions are visible and current
- Coordinate meetings, prepare materials, document decisions, and follow up with owners on assigned actions
- Help organize inspection evidence, procedures, training records, and filing-related documents for review by subject matter experts
- Maintain project and portfolio records, including project status, priorities, milestones, risks, resource needs, and dependencies
Requirements
- Bachelor's degree in Engineering
- Science
- Business
- Project Management
- Nice to have: pharmaceutical