Deviation Management Specialist

3 weeks ago


West Point, Pennsylvania, United States Integrated Resources, Inc Full time
Job Summary

We are seeking a highly skilled Deviation Management Specialist to join our team at Integrated Resources, Inc. This individual will be responsible for providing technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations.

Key Responsibilities
  • Provide day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations
  • Develop and implement corrective/preventative actions to prevent future deviations
  • Lead manufacturing and laboratory investigations to identify root causes of deviations
  • Collaborate with cross-functional teams to develop and implement process improvements
  • Support the development and implementation of quality systems and procedures
Requirements
  • Bachelor's or Master's degree in Mechanical or Chemical Engineering or other science degree
  • 0-3+ years of relevant work experience in a cGMP environment
  • Experience with troubleshooting biotech equipment, barrier technology, and closed system processing
  • Experience with Lean Six Sigma Methodologies and proven analytical/problem-solving capabilities
  • Excellent written and verbal communication skills


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