Batch Record Reviewer II - 2nd Shift
Amneal
Summary
Review batch records for timeliness and accuracy. Perform final review of manufacturing documentation across multiple production lines and support area for compliance and release.
Job description
Schedule
2nd Shift 3:30pm - 12:00am Monday to Friday
Essential Functions
- Evaluate, report and prepare data from documentation errors to management for trending and training; prepare and maintain MOS for all departments on monthly basis
- Review production batch records and related documents for accuracy and completeness
- Perform reconciliation of product yields after completion of manufacturing and/or packaging
- Preparing production batch records with in-process labels, forms and other related documents needed to process, evaluating inventory cards and submitting to pharmacy
- Maintain all production logbooks (ordering new logbooks, and sending completed to document control with tracking record) and communicating with document control for batch records, logbooks and other documents
- Review R&D batch records
- Review and update JDE entries and provide lot status updates to manager
- Co-ordinate with production planning department for work order, support 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.
Requirements
- High School or GED - Required
- 3 years or more in Manufacturing or Packaging
- Ability to read, write and communicate in English at a level to facilitate the understanding of the terminology of the job - Advanced
- Ability to comprehend and follow written and verbal procedures/instructions - Advanced
- Computer Knowledge (Excel and Power Point) - Advanced
- Have basic math and mechanical skills - Advanced
- Competent knowledge of SOP's and cGMP's
- Good problem solving skills
- Flexibility to rapidly adjust to changing job requirements
- Good communication skills
- This position requires successful completion of an OSHA-compliant Respirator Fit Test
Benefits
- Health insurance
- Insurance benefits
- 401(k) matching contribution
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.