Deviation Management Specialist

1 month ago


West Point, United States The Fountain Group LLC Full time
Currently I have an opening for a Deviation Management Specialist located in West Point, PA. Details for the position are as follows:
Job Description:
  • Leads and/or works as a team member on deviation investigations aimed to prevent deviation recurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting product impact assessment.
  • Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.
  • Supports and/or executes continuous improvement projects that increase compliance, simplify/ standardize, and/or gain efficiencies.
  • Manages timelines to ensure key compliance and customer due dates are met; escalates any potential misses and develops remediation plans when possible.
  • Assures consistent application of standardized work, engineering, and process tools.
  • Provides technical support to manufacturing shop floor for problems and issues.
  • Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
  • Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
  • Bachelor’s degree required, minimum 1 year of experience in GMP environment. Experience with quality assurance, technical writing, or deviation investigations is preferred.
Technical Information:
  • Pay: $35-41 hourly, depending on experience level
  • Onsite, M-F, 8am-5pm, Hybrid schedule after training
  • 12-month contract, potential for extension/conversion


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