FDA Program Coordinator

2 weeks ago


San Marcos, California, United States Texas State Full time
Job Title: FDA Program Coordinator

Join the Texas State University team as an FDA Program Coordinator, responsible for coordinating and providing oversight to the Food and Drug Administration (FDA) State Tobacco Compliance Check Inspection Program enforcement activities statewide.

Key Responsibilities:
  • Assist the Program Manager in serving as a liaison between FDA agency representatives, FDA state program staff, and FDA Inspectors and inspection teams.
  • Serve as a lead Contract Specialist and coordinate the work of other FDA Contract Specialists.
  • Provide ongoing training and direction to FDA Contract Specialists, and assist them in providing a consistent, coordinated approach to Inspector contract management.
  • Assist the Program Manager in maintaining and updating all program guides, standard operating procedures, quality assurance plans, etc. to meet ongoing program requirements, changes, and FDA audit guidelines.
  • Conduct ongoing technical assistance and performance monitoring of FDA Inspectors for programmatic quality assurance.
  • Assist the Program Manager in coordinating internal program functions to meet required FDA program requirements and timelines in all program areas.
Requirements:
  • Demonstrated experience managing contracts for service.
  • Demonstrated experience in using appropriate written and oral communication methods.
  • Demonstrated proficiency in all Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and Adobe.
  • Demonstrated ability to multitask.
  • Demonstrated experience in writing and generating reports that demonstrate a high attention to detail.
  • Demonstrated experience in creating and manipulating data in large electronic databases.
  • Demonstrated experience in handling and securing documents containing highly sensitive and confidential information.
Preferred Qualifications:
  • Bachelor's Degree.
  • Knowledge of Federal Tobacco Regulations.
  • Demonstrated experience in leading project teams.
  • Experience giving instructional presentations in a professional setting.

This is a full-time position, and the normal work hours are Monday through Friday, 8:00 AM to 5:00 PM. Occasional overnight travel may be required. The position offers up to 30 days remote work per fiscal year. Employment with Texas State University is contingent upon the outcome of a criminal background check. This position is funded via a Federal contract, and continued employment is conditional on annual renewal of the contract.



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