Batch Record Reviewer I

Job Description

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.
  
  
  

Qualifications

Education:

• High School or GED General - 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
• 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
  
  
  

Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.

The hourly base salary for this position ranges from $17.50 to $23.50 per hour. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.

About Us

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.