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QA Batch Record Specialist

Company: Akorn, Inc
Location: Jersey City
Posted on: November 22, 2021

Job Description:

The QA Batch Record Specialist reviews executed batch records and all associated documentation to ensure compliance with written Policies and procedures and completeness of documentation as required for batch release. This individual will work in a detail-oriented compliant manner to review records. This individual must be able to manage a work load of varying priorities while adhering to strict deadlines. The QA Batch Record Specialist can perform all tasks associated with QA Batch Record Reviewer with routinely demonstrated excellence.Perform first Quality review and release of executed batch records.Review and certify component release documentation and released Raw Material documentation for production use.Review QC Chemistry and Micro Certificates of Analysis for all applicable products manufactured.Review of specific in-process, and finished product test data.Document retrieval from local files and archives, as required for submissions and customer requests.Assist in process audits and internal audits as needed.Report Error Weekly Metrics (Right the First Time) found during review to ManagementWorks closely with QA functional teams to align and promote awareness on data integrity and good documentation practices.Report of weekly/monthly/quarterly metrics (Right the First time, Error free and Success Rate) to Quality Management.Facilitate and Coordinate with Project teams to enhance, improve and streamline batch records cycle timeNavigate through various online platforms, including JDE and Track WiseFacilitate and support online platforms implementation including Veeva and BMRAMInitiate product non-conformance investigations and deviation investigations in Track Wise as necessary. Assist in inter-departmental training and provide compliance guidance to personnel.Perform inter-departmental tasks as requested.Routine interaction with other departments for purposes of collecting batch record information or working to resolve documentation issues.

Keywords: Akorn, Inc, Jersey City , QA Batch Record Specialist, Other , Jersey City, New Jersey

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