Job Description

Description:

Review batch records for timeliness and accuracy. Perform final review of manufacturing documentation across multiple production lines and support area for compliance and release.

Essential Functions:

• Evaluate, report and prepare data from documentation errors to management for trending and training; prepare and maintain MOS for all departments on monthly basis
• Review production batch records and related documents for accuracy and completeness
• Perform reconciliation of product yields after completion of manufacturing and/or packaging
• Preparing production batch records with in-process labels, forms and other related documents needed to process, evaluating inventory cards and submitting to pharmacy
• Maintain all production logbooks (ordering new logbooks, and sending completed to document control with tracking record) and communicating with document control for batch records, logbooks and other documents
• Review R&D batch records
• Review and update JDE entries and provide lot status updates to manager
• Co-ordinate with production planning department for work order, support 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.