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Sr. QA Associate

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Location
Cincinnati, OH
Job Type
Direct Hire
Date
Mar 25, 2019
Job ID
2657758
 

This function is responsible for supporting the daily manufacturing and facility operations along with project support.  This is a Quality role in support of sterile manufacturing operations.  Functions include proactive support of change control assessments, documentation reviews and validation review/support.  Functions also include reactive support of discrepancy identification and resolution on the floor, Investigation Team Support, TrackWise (assessing product impact), and reporting operational metrics. This function supports and communicates events to shift leadership daily and thresholds when they are outside of the area of responsibility.

Knowledge/Skills Needed:

  • Strong written and oral communication skills. A thorough understanding of the regulatory process from GLP through commercial manufacturing.
  • Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
  • Experience in sterile and aseptic product qualification and quality.
  • Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
  • Experience in implementation and administration of quality systems for drug product development, manufacturing and quality control operations.
  • Project management experience including scheduling, tracking and auditing.
  • Experience in change management and deviation resolution including CAPA systems.   
  • Experience in participating in pharmaceutical technology transfer teams.
  • Experience in the qualification of facilities, utilities, equipment and processes.
  • Education & Experience Requirements:

  • Bachelor’s degree in a scientific discipline (or equivalent) with a minimum of 5 - 8 years’ experience in a Quality Assurance role in the pharmaceutical industry. 
  • Technical expertise and understanding of cGMP sterile filling manufacturing processes is required.  
  • Strong problem analysis (root cause analysis, risk assessment, and CAPA development) skills are a must. 
  • Experience in document and change control review/ approval is a must. 
  • Familiarity with Validation documentation and processes is a strong plus.  
  • Familiarity with SAP, CMMS, Trackwise, is a plus
  • Experience in direct interactions with FDA or other regulatory auditors is a plus.
  • Experience with sterile microsphere or powder manufacturing is a plus.