Job Information
Amneal Pharmaceuticals Batch Record Reviewer I in Brookhaven, New York
Description:
Review batch records for timeliness and accuracy.
Schedule:
1st Shift 7am - 3:30pm Monday to Friday
Essential Functions:
Perform final review of manufacturing documentation and provide support in areas of compliance for batch releases.
Provide lot status updates as requested.
Perform and/or support final release of batch records.
Document and submit reports and documentation errors to management, for trend and training analysis.
Provide support to the Compliance and Investigation groups, Quality Assurance- manufacturing floor groups during real time reviews, and also assist other departments with batch record retrieval and filing.
Provide support during internal/external audits, as requested.
Additional Responsibilities:
Perform additional duties as requested.
Participate in and support continuous improvement activities, maintain a clean and organized work space area to ensure compliance.