Batch Record Reviewer I - 1st Shift

Amneal • Piscataway, NJ

6d • $18 - $24

About The Position

The Batch Record Reviewer I is responsible for accurately and promptly reviewing batch records to ensure compliance with cGMP, internal quality standards, and regulatory requirements. The role verifies data entries, calculations, and documentation for completeness and accuracy; identifies and resolves discrepancies; and ensures deviations, investigations, and change controls are documented and addressed. The reviewer works with Production, Quality Assurance, and other cross-functional teams to support product release, maintain data integrity, and uphold product quality and patient safety.

Additional duties include supporting continuous improvement activities, maintaining an organized workspace, releasing production rooms, performing in-process checks and E-log book reviews or audits, entering engineering work orders and coordinating preventive maintenance tracking, and performing operator-level production responsibilities when needed. The role may also provide record retrieval and filing assistance across departments and support internal and external audits as requested.

Requirements

• High school diploma or GED.
• At least 2 years of experience in pharmaceutical, manufacturing, auditing, or related work.
• Competent knowledge of SOPs and cGMPs.
• Mechanical aptitude.
• Ability to identify issues and develop practical solutions.
• Flexibility to rapidly adjust to changing job requirements.
• Clear and professional communication skills.

Responsibilities

• Perform final review of manufacturing documentation for completeness and compliance with cGMP, SOPs, and regulatory requirements before release.
• Provide requested lot status updates to support production and quality activities.
• Ensure deviations, discrepancies, and non-conformances are documented and escalated for investigation.
• Document and report identified documentation errors to management and ensure they are tracked for trend analysis, training, and continuous improvement.
• Partner with QA–Manufacturing, Compliance, and Investigation groups during real-time reviews.
• Provide record retrieval and filing assistance across departments.
• Support internal and external audits as requested.
• Perform additional duties as requested.
• Participate in and support continuous improvement activities.
• Maintain a clean and organized workspace to ensure compliance.
• Release production rooms and perform in-process checks and review or audit E-log books.
• Enter engineering work orders and coordinate and track preventive maintenance activities.
• Perform operator-level job responsibilities in production areas as part of cross-functional activities when needed.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award.
• Long-term incentive award, such as restricted stock units, within the first 12 months.
• Health and insurance benefits.
• 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED