Batch Record Reviewer I - 1st Shift

Amneal

6d

About The Position

The Batch Record Reviewer I is responsible for accurately and promptly reviewing batch records for 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 collaborates with Production, Quality Assurance, and other cross-functional teams to support product release, preserve data integrity, and uphold product quality and patient safety.

Additional work may include supporting production activities, releasing production rooms, conducting in-process checks and E-log book reviews or audits, entering engineering work orders, coordinating and tracking preventive maintenance, and performing operator-level production responsibilities when needed. The position also supports continuous improvement and maintains a clean, organized workspace.

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.
• Competent 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 reviews 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 and 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 and maintain a clean, organized workspace.
• Release production rooms and conduct in-process checks and reviews or audits of E-log books.
• Enter engineering work orders and coordinate and track preventive maintenance activities.
• Perform operator-level responsibilities in production areas as part of cross-functional activities, if 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 for eligible positions.
• 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