Batch Record Reviewer III
Amneal
Summary
Ensure good record keeping of all manufacturing related documentations. Provide log of corrections and provide support to department during training. Review batch records for timeliness and accuracy. Perform final review of manufacturing documentation and provide support in areas for compliance and batch release.
Job description
Essential Functions
- Manage batch records for all packaging and manufacturing areas, enter deviations on batch records before submitting to the production floor, review PO's and other related documents for accuracy and completeness.
- Ensure proper record keeping all production logbooks, send completed logbooks to the document-control department with a record of completion tracker. Update files according to the newest version from Document Control.
- Evaluate operators' documentation errors and communicate results to the department supervisor, provide guidance and training.
- Work with the Quality Assurance and Warehouse departments to submit labeling requisition forms for production components, according to monthly schedule.
- Review all R&D batch records. Review and update JDE entries.
- Communicate new batch records, new logbooks, official documentations, etc to the Document Control team.
- Complete entries in the APR web application, to ensure proper tracking of all batch records.
Additional Responsibilities
- Order and ensure office supplies are available for department.
Qualifications
Education: High School or GED - Required
Experience: 5 years or more in Pharmaceutical, manufacturing, auditing or related experience
Skills
- 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
- Ability to apply basic math and mechanical skills - Advanced
- Good organization skills, clerical skills, and ability to multi-task - Advanced
Specialized Knowledge
- Competent knowledge of SOP's and cGMP's, Computer Knowledge (Excel and Power Point)
- Good problem solving skills
- Flexibility to rapidly adjust to changing job requirements
Requirements
- High School diploma or GED
- 5 years or more in Pharmaceutical, manufacturing, auditing or related experience
- Ability to read, write and communicate in English at an advanced level
- Ability to comprehend and follow written and verbal procedures/instructions
- Ability to apply basic math and mechanical skills
- Good organization skills, clerical skills, and ability to multi-task
- Competent knowledge of SOPs and cGMPs
- Computer knowledge (Excel and PowerPoint)
- Good problem solving skills
- Flexibility to rapidly adjust to changing job requirements
Benefits
- Health Insurance
- Insurance Benefits
- 401(k) Matching
- Short-Term Incentive
- Performance-Based Award
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.