Deviation Management Specialist

1 month ago


Lansdale, Pennsylvania, United States eTeam Full time
Job Title: Deviation Management Specialist

Join eTeam as a Deviation Management Specialist and play a crucial role in ensuring the highest standards of quality and compliance in our manufacturing operations.

Key Responsibilities:
  • Lead and/or participate in deviation investigations to identify root causes and implement corrective actions.
  • Collaborate with cross-functional teams to develop and implement process improvements that increase compliance and efficiency.
  • Manage timelines to ensure key compliance and customer due dates are met, and escalate potential misses to develop remediation plans.
  • Provide technical support to the manufacturing shop floor for problems and issues, and conduct experimental protocols as needed.
  • Author and update technical and manufacturing documents necessary for investigations, process design, and change control.
Requirements:
  • Bachelor's degree in Engineering or Sciences.
  • Minimum one year of post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations.
  • Demonstrated ability to drive results to hit assigned due dates, strong communication and collaboration skills, and a strong problem-solving skillset.
Preferred Qualifications:
  • Vaccine manufacturing experience.
  • Sterile processing experience.
  • Technical writing experience, including investigations and technical protocols/reports.
  • Investigative tools experience, including 5-whys and fishbone diagrams.


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