Deviation Management Specialist - I Assistant
Deviation Management Specialist - I Assistant
Posted on :
20-10-2024
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Job Description
Qualifications Education Minimum Requirements: B.S. degree in Engineering or Sciences. Required Experience and Skills: Minimum one (1) year postbachelor s degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with < 1 year experience). Demonstrated ability to drive results to hit assigned due dates. Strong communication collaboration skills and ability to drive accountability. Strong problemsolving skillset. Preferred Experience and Skills: Vaccine manufacturing Sterile processing Technical writing (e.g. investigations technical protocols/reports) Investigative tools (e.g. 5whys fishbone) Experience authoring investigations for atypical events in a manufacturing environment
Responsibilities 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.
Comments/Special InstructionsBrief team meeting. Assign investigations. Work on investigations (interviewing others writeup at desk SAP data mining). 80% Desk/20% meetings
System Location: Manufacturing (Z007) Required
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CWR Type: W2 Required
Responsibilities 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.
Comments/Special InstructionsBrief team meeting. Assign investigations. Work on investigations (interviewing others writeup at desk SAP data mining). 80% Desk/20% meetings
System Location: Manufacturing (Z007) Required
Job Title: XX(document).ready(function () var XXlnkJobTitle XX(#ctl00CPHucClientJobTitleDoclnkJobTitle); XXlnkJobTitle.attr(href #); XXlnkJobTitle.on(click function (event) event.preventDefault(); var url XX(this).attr(url); var filepath XX(this).attr(filepath); var doccount XX(this).attr(doccount); if (doccount > 1) EP.openDialog(url); else window.open(url url : filepath); ); ); Deviation Management Specialist I (Assistant)
CWR Type: W2 Required
Employment Type
Full Time
Key Skills
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