Batch Record Reviewer II - 2nd Shift

Amneal Pharmaceuticals LLC; United States; On-site; USD 28,000 - 36,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a detail-oriented team member for 2nd shift (3:30pm–12:00am, Mon-Fri) to review batch records and supporting documents across production lines. The role ensures compliance, data accuracy and timely release of manufactured products.

The candidate will coordinate with production planning, maintain logbooks, and support internal audits. Requirements include High School or GED, 3+ years in Manufacturing or Packaging, strong English communication, and proficiency

Qualifications

• Must read, write and communicate in English at an advanced level.
• Ability to follow written and verbal procedures/instructions.
• Basic math and mechanical skills.
• 3+ years in Manufacturing or Packaging.

Responsibilities

• Review batch records for timeliness and accuracy, and support area for compliance and release.
• Evaluate, report and prepare data from documentation errors for management, and maintain MOS monthly.
• Perform reconciliation of product yields after manufacturing/packaging.
• Prepare production batch records with in-process labels and related documents.

Skills

English Proficiency

Procedural Compliance

Math Basics

Mechanical Skills

Communication Skills

Problem Solving

Education

High School or GED

Tools

Excel

PowerPoint

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.

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

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.

Education:

• High School or GED - Required

Experience:

• 3 years or more in Manufacturing or Packaging

Skills:

• 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

Specialized Knowledge:

• Competent knowledge of SOP's and cGMP's
• Good problem solving skills
• Flexibility to rapidly adjust to changing job requirements
• Good communication skills

Additional Requirement:

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

The hourly base salary for this position ranges from $20.50 to $26.00 per hour. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.