Batch Records Specialist II — 2nd Shift Compliance & QA

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

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.