Temp-Compliance Coordinator (Complaints)

Summary: Acts as initial point of contact for receiving and processing complaint notifications. Receives and processes returned complaint samples. Performs examination of complaint and reserve samples. Maintains compliance with site procedures. Becomes involved as required to meet schedules or resolve problems.

Essential Duties and Responsibilities include, but are not limited to, the following:

• • Monitor complaint notifications from group mailbox
• • Enter complaint intake data into Process Compliance system and Complaint Master tracking sheet
• • Verify required documentation and content received
• • Evaluate and assign initial classification of event or complaint
• • Correspond with personnel and contractors (Call Center, Regeneron Distribution, Clinical Trial Management, etc.) as required to request or obtain additional information related to complaint reports
• • Process receipt of complaint samples
• • Examine and evaluate complaint and retain samples for defects
• • Obtain photographic evidence, record sample data, enter observations and evidence into LIMS
• • Process complaint samples for destruction
• • Assist with delivery of complaint samples to QC for testing
• • Retrieve, copy/scan and maintain batch documentation used to support complaint investigations
• • Perform general administration activities in support of the complaint team

Education and Experience:

• • Requires high school diploma with 2+ years of relevant work experience or BS/BA in scientific discipline or related field