Batch Record Reviewer I - 1st Shift

Description: 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.

Essential Functions:

• 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.

Additional Responsibilities:

• 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

Education:

• High School or GED - Required

Experience:

• 2 years or more in Pharmaceutical, manufacturing, auditing or related experience

Specialized Knowledge:

• 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

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. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

 

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [email protected]. Requests will be handled confidentially and in accordance with applicable laws.