Batch Record Reviewer I - 1st Shift

About the role

The Batch Record Reviewer I is responsible for the accurate and timely review of batch records to ensure compliance with cGMP, internal quality standards, and regulatory requirements. This role involves verifying data entries, calculations, and documentation for completeness and accuracy, identifying and resolving discrepancies, and ensuring that all deviations, investigations, and change controls are properly documented and addressed. The reviewer works closely with Production, Quality Assurance, and other cross-functional teams to support product release, maintain data integrity, and uphold product quality and patient safety.

Responsibilities

• Perform final review of manufacturing documentation for completeness and compliance with cGMP, SOPs, and regulatory requirements before release
• Deliver requested lot status updates to support production and quality activities
• Ensure that deviations, discrepancies, and non-conformances are properly documented and escalated for investigation
• Document and report identified documentation errors to management, ensuring proper tracking for trend analysis and use in training and continuous improvement initiatives
• Support compliance and quality initiatives by partnering with QA–Manufacturing, Compliance, and Investigation groups during real-time reviews, and providing record retrieval and filing assistance across departments
• Provide support during internal/external audits, as requested
• Perform additional duties as requested
• Participate in and support continuous improvement activities, maintain a clean and organized work space area to ensure compliance
• Release of production rooms, along with in-process checks and review/audit of E-log books
• Entry of engineering work orders, including coordination and tracking of preventive maintenance activities
• Performing operator-level job responsibilities in production areas as part of cross-functional activities, if needed

Requirements

• High School or GED — Required
• 2 years or more in Pharmaceutical, manufacturing, auditing or related experience
• Competent knowledge of SOPs, cGMPs and competent mechanical aptitude
• Ability to identify issues and develop practical solutions
• Flexibility to rapidly adjust to changing job requirements
• Clear and professional communicator

Pay

The hourly rate for this position ranges from $17.50 – $23.50 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months.

Benefits

Amneal offers a comprehensive, flexible and competitive benefits program for eligible positions, including above-market, diverse and robust health and insurance benefits, a significant 401(k) matching contribution, and programs that promote employee well-being.