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Deviation Management Specialist

1 month ago

West Point, Pennsylvania, United States Collabera Full time
Job Title: Deviation Management Specialist

Collabera is seeking a highly skilled Deviation Management Specialist to join our team. As a Deviation Management Specialist, you 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
  • Resolve and reduce process deviations
  • Develop and implement corrective/preventative actions
  • Lead manufacturing and laboratory investigations
  • Provide scientific support for manufacturing areas
  • Troubleshoot and root cause analysis of laboratory test failures and manufacturing atypical events
  • Develop working relationships with counterparts in other areas supporting aseptic manufacturing, testing, planning, and release
Requirements:
  • B.S./M.S. degree in an appropriate engineering/scientific field
  • Minimum of 0-3 years post-Bachelors degree experience in a cGMP environment
  • Previous experience in writing investigations for atypical events in a manufacturing environment
  • Familiar with Lean Six Sigma Methodologies and proven analytical/problem-solving capabilities
  • Demonstrated ability to work both independently and as a part of a cross-functional team
  • Excellent written and verbal communication skills