Batch Record Reviewer I at Amneal Pharmceuticals of New York LLC in Brookhaven, New York

Job Description:

Description:

• Review batch records for timeliness and accuracy.

Essential Functions:

• Perform final review of manufacturing documentation and provide support in areas of compliance for batch releases.

• Provide lot status updates as requested.

• Perform and/or support final release of batch records.

• Document and submit reports and documentation errors to management, for trend and training analysis.

• Provide support to the Compliance and Investigation groups, Quality Assurance- manufacturing floor groups during real time reviews, and also assist other departments with batch record retrieval and filing.

• 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.

Education:

• High School or GED - Required

Experience:

• 2 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 or instructions Computer Knowledge (Excel and Power Point) - Advanced

• Ability to apply basic math and mechanical skills - Advanced

Specialized Knowledge:

• Competent knowledge of SOPs, cGMPs and competent mechanical aptitude

• Good problem solving skills

• Flexibility to rapidly adjust to changing job requirements

• Good communication skills