Batch Record Reviewer II - 2nd Shift

Amneal Pharmaceuticals LLC; Town of Brookhaven (NY); On-site; USD 44,000 - 54,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a 2nd shift Batch Records Reviewer to ensure timeliness and accuracy in manufacturing documentation across multiple lines. The role involves data evaluation, MOS preparation, and collaboration with production planning to support audits and compliance.

Responsibilities include reviewing batch records, performing reconciliations, maintaining logbooks, and updating JDE entries to provide accurate lot status. OSHA respirator fit test completion is required.

Qualifications

• High School diploma or GED required.
• 3+ years in Manufacturing or Packaging.
• Ability to read, write and communicate in English at an advanced level.
• Proficiency with Excel and PowerPoint.

Responsibilities

• Review batch records and related documents for accuracy and completeness.
• Evaluate data from documentation errors for trending and training; prepare MOS monthly.
• Prepare production batch records with in-process labels, forms and related documents.
• Maintain production logbooks and coordinate with document control for batch records.

Skills

English proficiency

Procedures compliance

Excel/PowerPoint

Math/Mechanical skills

Education

High School or GED

Tools

JDE

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.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.