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Scientific. Clinical. Software Engineering

Compliance Specialist

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -022020-26391 Region: Edison-New Brunswick Metro Area

Job Description

Quality Specialist

The Quality Specialist will work in the Quality Assurance Department at Ridgefield, NJ to support the Supplier Management team.

Job Responsibilities

Investigation of Supplier Corrective Action Requests (SCARs)

Investigate issues associated with purchased materials

Work with suppliers to identify corrective actions to prevent reoccurrence

Processing of Supplier Change Notifications (SCNs)

Review of supplier change notification against Approved Supplier List to determine if material is used at Ridgefield

Routing SCN for assessment to appropriate subject matter experts

Facilitate SCN meetings for significant changes to determine actions required

Create works in Phenix SCN workflow for actions required

Sending out periodic reports of open works to work owners and department managers

Compiling SCN metrics and following up with responsible parties

Writing Quality Agreements

Minimum Job requirements

Bachelor s degree in either Biology, Chemistry, or other life science

Minimum of 5 years of experience working in Quality in Pharmaceutical or Medical Device Company

Preferred Experience

Experience working in Supplier Quality or Investigations

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