Senior Peer Reviewer

Peer Reviewer III is responsible for reviewing and approving data generated by the laboratory to ensure accuracy and compliance with procedures and cGMP requirements. The role completes audit tasks within a specified time frame without compromising audit quality, continuously improves the documentation system to increase efficiency and GLP compliance, reports audit findings in audit reports and highlights, and reports any critical deficiencies.

Essential Functions

Review laboratory testing records with respect to written procedures/specifications, SOPS, and company policies.

Review laboratory instrument calibration/qualification records, standard qualification records and records associated with investigations.

Review Raw-material, Excipients, Finished Product for data integrity, compliance with Specifications, Methods and USP monographs as applicable.

Review Analytical Method Validation/Verification data for compliance with Protocols and ICH guidelines.

Review stability data to identify any trends, alert limits and OOS.

Participation in audit of laboratory activities to determine improvement needs for maintenance of cGMP compliance.

Prepare for Pre-Approval Audits for Filed ANDAs.

Additional Responsibilities

Perform other duties as assigned.

Qualifications
Education:

Bachelors Degree (BA/BS) - Required

Experience:

6 years or more in scientist or group leader in pharmaceutical lab

Required Skills

Analytical Chemistry

Biochemical Assays

Chromatography

Decision Making

Detail Oriented

Good Manufacturing Practices

New Product Development

Process Validation

Quality By Design (QbD)

Troubleshooting (Problem Solving)

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 accommodations@amneal.com . Requests will be handled confidentially and in accordance with applicable laws.

Job Info

Job Identification 7953

Job Category Analytical R&D

Posting Date 05/27/2026, 01:36 PM

Locations 1045 Centennial Avenue, Piscataway, NJ, 08854, US

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