Quality Compliance Coordinator
Found in: Talent US C2 - 2 weeks ago
The Quality Compliance Coordinator acts as initial point of contact for receiving and processing complaint notifications. They receive and process returned complaint samples and performs 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.
In this role, a typical day may include 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 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
This role may be for you if you:
Excel in a quality driven organization
Have an understanding of biologics manufacturing operations
Are organized and have an attention to detail
Can prioritize multiple assignments and changing priorities
Are able to learn and utilize computerized systems for daily performance of tasks
To be considered for this role you must hold a BS/BA in scientific discipline or related field and the following minimum amounts of experience for each level:
Quality Compliance Coordinator: 3+ years
Relevant experience may be considered in lieu of degree.
#REGNQA
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