Batch Record Reviewer II - 2nd Shift
$20.5 - $26 per hourFull-time
Amneal Pharmaceuticals
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. Schedule: 2nd Shift 3:30pm - 12:00am Monday to Friday 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
- Perform additional duties as requested. Participate in and support continuous improvement activities, maintain a clean and organized work space area to ensure compliance.
- High School or GED - Required
- 3 years or more in Manufacturing or Packaging
- Ability to read, write and communicate in English at a level to facilitate the understanding of the terminology of the job - Advanced
- Ability to comprehend and follow written and verbal procedures/instructions - Advanced
- Computer Knowledge (Excel and Power Point) - Advanced
- Have basic math and mechanical skills - Advanced
- Competent knowledge of SOP's and cGMP's
- Good problem solving skills
- Flexibility to rapidly adjust to changing job requirements
- Good communication skills
Vacancy posted 6 days ago
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