$28 - $33.78 per hr
6 month contract - may extend or convert but no guarantee
San Diego, CA - fully onsite role
Duties:
- Regularly monitors Complaint Handling inbox for new complaints and adverse event reports
- Generates complaints in the eQMS and adds data inputs to Master Complaint Tracker
- Attaches all relevant files and reports for the complaint to the eQMS e.g. PC/AE reports, Follow-Up communications, Reportability Assessments, log files etc.
- Organizes and generate Complaint folders in SharePoint to help with investigations and collaboration activities
- Performs DHR review for Complaint investigations
- Updates Complaint investigation summary with administrative information including complaint number, PC/AE report information, Device information etc.
- Creates- log files and attaches to the eQMS and SharePoint Complaint folder
- Monitors Handpiece returns inventory and places weekly requests with 3PL for return shipments
REQUIRED:
- Minimum 1-3 years of relevant Pharmaceutical/Medical Device Industry Quality Assurance experience
- Must have some complaint handling experience in the biopharma or medical device indistries