Batch Record Reviewer II

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 28,000 - 37,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Bonus/incentive program

Job summary

Amneal Pharmaceuticals is seeking a detail-oriented batch records reviewer to support manufacturing by ensuring timeliness and accuracy of documentation across multiple lines. This role involves error reporting, MOS maintenance, and continuous improvement contributions within a GMP environment.

Responsibilities include reviewing production records, reconciling yields, preparing batch documentation, and coordinating with planning and audits.

Qualifications

• Must read, write and communicate in English to understand job terminology.
• Follow written and verbal procedures/instructions.
• Proficient in Excel and PowerPoint.
• Basic math and mechanical skills.

Responsibilities

• Review batch records for timeliness and accuracy; support documentation for compliance and release.
• Evaluate and report documentation errors to management for trending and training; maintain MOS monthly.
• Review production batch records and related documents for accuracy and completeness.
• Perform reconciliation of product yields after manufacturing/packaging.
• Prepare production batch records with in-process labels and related documents.
• Maintain production logbooks and coordinate with document control for batch records.
• Review R&D batch records and update JDE entries; provide lot status updates.
• Coordinate with production planning for work orders and audits.

Education

High School diploma or GED

English reading/writing

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.

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

The hourly rate for this position ranges from $20.50 to $26.50 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what 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, experience, 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 help 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.