Batch Record Reviewer II - 2nd Shift

Amneal

1d • Onsite

About The Position

Review batch records for timeliness and accuracy. Perform final review of manufacturing documentation across multiple production lines and support area for compliance and release. This position is for the 2nd Shift, from 3:30 PM to 12:00 AM, Monday to Friday.

Requirements

• 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
• This position requires successful completion of an OSHA-compliant Respirator Fit Test.

Responsibilities

• 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.

Benefits

• Above-market, diverse and robust health and insurance benefits
• Significant 401(k) matching contribution
• Programs that help you enjoy your career alongside life’s many other commitments and opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED