FTE Senior Deviation / Investigation Writer (Operations)

Company: Katalyst Healthcares & Life Sciences
Location: Wilson
Posted on: March 17, 2023

Job Description:

Responsibilities:

• 
  
• The Senior Deviation/Investigation Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Technical Operations (Manufacturing and Packaging) department.
  
• Perform investigation activities and writing deviation investigation reports for the Technical Operations (Manufacturing and Packaging) department.
  
• Coordinate prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
  
• Write concise and accurate investigation reports.
  
• Utilize various root cause analysis, analytical and problem-solving tools to determine root cause of GxP deviations and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent recurrence.
  
• Participate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation process.
  
• Update, author and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs.
  
• Initiate Change Controls as required for Manufacturing and Packaging operations.
  
• Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.
  
• Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.
  
• Perform other related assignments and duties as required and assigned.
  
  Requirments:
  
  
  • 
    
  • Requires a bachelor's degree, preferably in a scientific discipline, with a minimum of 3-5 years of experience in a pharmaceutical or related industry.
    
  • Demonstrate a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing/packaging processes.
    
  • Minimum of 3 years manufacturing or technical experience in a regulated GxP environment, oral solid dosage manufacturing/packaging preferred.
    
  • Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving capabilities in a GxP environment.
    
  • Demonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear and accurate.
    
  • Demonstrated ability to work independently and as part of a collaborative, cross-functional team.
    
  • Working knowledge of Trackwise or similar deviation management system.
    
  • Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.
    
  • While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.
    
  • Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.
    

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