Batch Records Quality Reviewer I

Amneal Pharmaceuticals LLC (J0P); Piscataway Township (NJ); On-site; USD 24,000 - 32,000; Full time

Benefits offered by this job

Health benefits

401(k) matching

Job summary

Amneal Pharmaceuticals LLC is seeking a Batch Record Reviewer I to ensure accurate, timely review of batch records in a cGMP environment. You will verify data, support product releases, and collaborate with QA, Production, and other teams to uphold quality and patient safety.

The role requires a High School diploma or GED and at least 2 years in pharmaceutical manufacturing or related fields, with strong SOPs/cGMP knowledge and problem-solving abilities.

Qualifications

• SOPs and cGMPs proficiency required.
• Ability to identify issues and provide practical solutions.
• Strong communication and collaboration with QA/Manufacturing.

Responsibilities

• Perform final review of manufacturing documentation for completeness and compliance before release.
• Deliver requested lot status updates to support production and quality activities.
• Ensure deviations and non-conformances are documented and escalated for investigation.
• Document and report identified documentation errors for trend analysis and training.
• Support audits and cross-functional record retrieval across departments.
• Release of production rooms and in-process checks; review of E-log books.
• Enter and coordinate engineering work orders and preventive maintenance activities.
• Participate in cross-functional activities in production areas as needed.

Skills

SOPs knowledge

cGMP knowledge

Mechanical aptitude

Issue identification

Clear communicator

Education

High School or GED

Job description

Amneal Pharmaceuticals LLC is seeking a Batch Record Reviewer I to ensure accurate, timely review of batch records in a cGMP environment. You will verify data, support product releases, and collaborate with QA, Production, and other teams to uphold quality and patient safety.

The role requires a High School diploma or GED and at least 2 years in pharmaceutical manufacturing or related fields, with strong SOPs/cGMP knowledge and problem-solving abilities.