Quality Compliance Coordinator

Found in: Talent US C2 - 2 weeks ago


Albany, United States Regeneron Pharmaceuticals, Inc Full time

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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