Batch Record Reviewer III

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 33,000 - 44,000; Full time

Job summary

Amneal Pharmaceuticals in New Jersey is seeking a Records Specialist to manage manufacturing batch records, maintain quality documentation, and support training. You will review timeliness and accuracy of batch records and assist with document control processes to ensure compliance.

This role requires attention to detail, strong English communication, and the ability to multi-task in a fast-paced environment. The hourly rate is competitive with incentive opportunities and comprehensive benefits.

Qualifications

• 5+ years in pharmaceutical manufacturing, auditing or related experience.
• Ability to read, write and communicate in English at an advanced level.
• Strong organizational, clerical and multitasking capabilities.
• Familiarity with cGMP and document control practices is a plus.

Responsibilities

• Manage batch records for packaging and manufacturing areas, enter deviations and review documents.
• Maintain production logbooks and forward completed logs to Document Control with trackers.
• Support training and provide guidance on documentation errors to operators.
• Coordinate with QA and Warehouse to submit labeling requisition forms per schedule.
• Review R&D batch records and update JDE entries as needed.
• Communicate new batch records and official documents to Document Control.
• Complete entries in the APR web application for batch record tracking.

Skills

English proficiency

Communication skills

Organization skills

Clerical skills

Multi-tasking

Education

High School or GED

Tools

Excel

PowerPoint

Job description

Job Description

Ensure good record keeping of all manufacturing related documentations. Provide log of corrections and provide support to department during training. Review batch records for timeliness and accuracy. Perform final review of manufacturing documentation and provide support in areas for compliance and batch release.

Essential Functions

• Manage batch records for all packaging and manufacturing areas, enter deviations on batch records before submitting to the production floor, review PO’s and other related documents for accuracy and completeness.
• Ensure proper record keeping all production logbooks, send completed logbooks to the document-control department with a record of completion tracker. Update files according to the newest version from Document Control.
• Evaluate operators’ documentation errors and communicate results to the department supervisor, provide guidance and training.
• Work with the Quality Assurance and Warehouse departments to submit labeling requisition forms for production components, according to monthly schedule.
• Review all R&D batch records. Review and update JDE entries.
• Communicate new batch records, new logbooks, official documentations, etc to the Document Control team.
• Complete entries in the APR web application, to ensure proper tracking of all batch records.

Additional Responsibilities

• Order and ensure office supplies are available for department.

Qualifications

Education

• High School or GED - Required

Experience

• 5 years or more in Pharmaceutical, manufacturing, auditing or related experience

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
• Ability to apply basic math and mechanical skills - Advanced
• Good organization skills, clerical skills, and ability to multi-task - Advanced

Specialized Knowledge

• Competent knowledge of SOP's and cGMP's , Computer Knowledge (Excel and Power Point)
• Good problem solving skills
• Flexibility to rapidly adjust to changing job requirements

Salary & Benefits

The hourly rate for this position ranges from $24.00 to $32.00 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.

About Us

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.