Job Title: Sr. Associate, NAM Cluster Quality Support
Location: Princeton, NJ
A global leader in pharmaceutical manufacturing is looking for a Sr. Associate, NAM Cluster Quality Support to assist the North America Quality for Drug Product Recalls, Field Alert Reports, and monthly Recall Reports. The Sr. Associate will be responsible for supporting the NAM Cluster Quality team by being the liaison for multiple sites' Product Quality Complaints and complaint sample management.
Main Responsibilities
- Manage FARs including the submission of all FARs, answer related FDA queries
- Attend Global Recall Committee Meetings
- Manage US Drug Product Recalls including all submissions to the FDA
- Manage third party service provider for US Product Quality Complaints, maintain company master list for complaint samples intake
- Review investigations, provide guidance, and routinely follow-up with sites
- Support North America region compliance activities
Necessary Qualifications
- 10+ years in a regulated pharmaceutical industry within QA/QC
- Experience with creation of FARs
- Experience conducting US Drug Recalls
- Experience conducting technical reviews and writing (investigations, test methods, SOPs, Corporate Policies, Global Quality Standards)
If this position sounds interesting to you, please don't hesitate to apply!
