Batch Record Reviewer III at Amneal Pharmaceuticals of New York LLC in Brookhaven, New York

Job Description:

Job 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. 

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.

Education

• High School or GED - Required

Work Experience

• 5 years or more Pharmaceutical, manufacturing, auditing or related experience - Required

Skills and Abilities

• 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

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.