Batch Record Reviewer I

Amneal

7d • $18 - $24

About The Position

Description: Review batch records for timeliness and accuracy. Schedule: 1st Shift 7am - 3:30pm Monday to Friday 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.

Requirements

• High School or GED General - Required
• 2 years or more in Pharmaceutical, manufacturing, auditing or related experience
• 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
• Competent knowledge of SOPs, cGMPs and competent mechanical aptitude
• Good problem solving skills
• Flexibility to rapidly adjust to changing job requirements
• Good communication skills
• 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
• This position requires successful completion of an OSHA-compliant Respirator Fit Test.

Responsibilities

• 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.
• Perform additional duties as requested.
• Participate in and support continuous improvement activities, maintain a clean and organized work space area to ensure compliance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees