- 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) in order 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.
Qualifications :
Education Minimum Requirements :
degree in Engineering or Sciences.
Required Experience and Skills :
- Minimum one () year post-bachelor's degree experience in a GMP (good manufacturing practices) manufacturing and / or technical support of GMP manufacturing operations (or degree with < year experience).
- Demonstrated ability to drive results to hit assigned due dates.
- Strong communication, collaboration skills and ability to drive accountability.
- Strong problem-solving skillset.
Preferred Experience and Skills :
- Vaccine manufacturing
- Sterile processing
- Technical writing ( investigations, technical protocols / reports)
- Investigative tools ( -whys, fishbone)
- Experience authoring investigations for atypical events in a manufacturing environment
Deviation Management Specialist - I
Deviation Management Specialist - I. ...
Deviation Management Specialist
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Job Title: Deviation Management Specialist - I Location: West Point, PA Hours/Schedule: Mon- Fri 8am-5 pm Type: Contract Responsibilities Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, developm...
Deviation Management Specialist - I
Deviation Management Specialist - I. Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory invest...
Deviation Management Specialist
Deviation Management Specialist. 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. Experience wit...
Deviation Management Specialist
Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing investigations. This Individual will also develop working ...
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Deviation Management Specialist - I. Primary responsibilities include day-to-day technical support to manufacturing operations, including resolution and reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory invest...
Deviation Management Specialist - I (Assistant) Deviation Management Specialist - I (Assistant)
Primary responsibilities include day-to-day 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. This Individual will also d...
Deviation Management Specialist
Title: Deviation Management Specialist. ...