Batch Record Reviewer I - 1st Shift
Amneal
Summary
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.
Job description
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.
Qualifications
- 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
Requirements
- High School diploma or GED
- 2 years or more in Pharmaceutical, manufacturing, auditing or related experience
- 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 communicator
Benefits
- Health Insurance
- Short-term incentive
- Long-term incentive
- Restricted stock units
- 401(k) Matching
Company overview
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a leading American publicly traded pharmaceutical company headquartered in Bridgewater, New Jersey. Founded in 2002 by brothers Chirag and Chintu Patel, the company has grown to become one of the largest and fastest-growing generic pharmaceutical manufacturers in the United States. Amneal operates as an integrated pharmaceutical company focused on developing, manufacturing, and distributing generic, brand, and biosimilar products. With approximately 8,100 employees globally, the company maintains operations across North America, Asia, and Europe. Amneal's business is organized into three main segments: a robust U.S. generics business with over 250 product families, a growing specialty pharmaceuticals division focused on central nervous system disorders and endocrine conditions, and an expanding biosimilars portfolio. The company has established itself as a leader in complex dosage forms and difficult-to-manufacture products, with manufacturing capabilities spanning oral solids, injectables, ophthalmics, liquids, topicals, transdermals, and respiratory devices. Amneal's mission 'We make healthy possible' reflects its commitment to providing affordable access to essential medicines while maintaining high-quality standards across its global operations.