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Quality Specialist
Ref No.: 18-08979
Location: Ridgefield, New Jersey
The QA Product Release Associate is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations and established procedures. They support the review of batch records, assemble and review batch files, support the completion of the annual product review, maintain and utilize Quality Assurance databases, utilize the SAP System, review documentation for compliance with cGMPs, FDA, ICH and other regulatory requirements and perform administrative tasks.
Reviews manufacturing BPR (batch production records) to ensure compliance with internal specifications and cGMPs.
Assures documentation is in compliance with cGMP regulations and ISO 13485 guidelines.
Compiles device history record (DHR) for medical lots in preparation for product release.
Drafts and reviews specifications and SOPs.
Monitors and trends batch record errors and provides Quality Assurance management with metrics.
Draft and provide Quarterly Metrics/ Yearly Metrics to Quality Assurance Management.
Assist Departments with Process Improvement Projects.
Provide Quality Investigation Group with BPR's and QC data to support Deviations closure.
Perform Batch record closure and Product disposition. Maintain and complete non-conformances containment tasks using the TrackWise and SAP system.

Experience writing/reviewing SOPs
Able to navigate various computer platforms (LiveLink, StarLIMs, SAP and TrackWise)