• Review of manufacturing documentation for compliance to GDP and CPP prior to submission to QA
• Provide on the floor document review of batch records and support for Manufacturing teams
• Evaluate trend data for process improvement
• Deliver training to manufacturing teams on SOP/Process changes
• Execute document and process improvement changes
• Track and Trend RFT metrics

Primary Responsibilities:

• Perform review of Manufacturing Documentation across multiple production lines
  
  • Ensure all Manufacturing Documents are fully reviewed before submission to the Batch Release Group
  • Provide on the floor document review and recommendations for error corrections
• Support manufacturing teams to provide feedback on error trends and area of focus
  
  • Record and maintain data to track batch record turnaround time, errors and document related deviations
  • Track training activities and curriculums to ensure compliance is consistently maintained
• Partner with Training, Industrialization, Engineering, Quality, Supply Chain and Manufacturing departments to provide detailed training on SOP and process changes to ensure compliance
  
  • Provide improvement ideas on documentation and processes
  • Complete change control to ensure that improvement ideas are fully implemented. 
• Partner with the investigation team to promote timely correction and closure of Non-Conformances
• Perform any additional job related duties as requested

Education, Skills, & Experience:

• HS diploma/GED and a minimum of 4 years experience in a regulated production/operations environment
  • Associate degree (or higher) & 2 years experience in a regulated production/operations environment
• Experience in FDA regulated environment with knowledge of Good Manufacturing Practices
• Experience in Batch Record review in a regulated production/operations environment
• Experience in continuous improvement, project management and delivering of training preferred
• Ability to translate written instructions, work orders and specifications.
  • Knowledge of FDA and/or GMP regulations required
  • Quality documentation review in production facility preferred.
  • Excellent interpersonal skills and ability to work with all levels of an organization
• Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands
  • Must be able to work effectively in a team based and individual environment.
  • Must be able to deliver negative and positive feedback effectively.  
  • Must hold to the highest level of accountability and integrity
• Knowledge of Microsoft Word, Excel, PowerPoint and Outlook required.  
  
  • SAP experience preferred
• Strong analytical and problem-solving skills.  
• Leadership experience preferred

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