Quality Compliance Coordinator (Complaints)

Role Summary

The Quality Compliance Coordinator acts as initial point of contact for receiving and processing complaint samples. They receive and process returned complaint samples and perform examination of complaint and reserve samples. They will also maintain compliance with site procedures and become involved as required to meet schedules or resolve problems.

Responsibilities

• 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 the need arises to request or obtain additional information related to complaint reports
• Process receipt of complaint samples
• Examine and evaluate complaint and retain samples for defects
• Acquire 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

Qualifications

• Required: BS/BA in scientific discipline or related field
• Required: 0-3 years of experience for Quality Compliance Coordinator
• Relevant experience may be considered in lieu of degree

Skills

• Excel in a quality driven organization
• Understanding of biologics manufacturing operations
• Organized with attention to detail
• Ability to prioritize multiple assignments and changing priorities
• Ability to learn and utilize computerized systems for daily tasks