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Change Control Specialist
1 week ago
Details for the position are as follows:
Job Description:
$43.62/HR to start 9-month assignment (with potential to extend or convert based on performance and budget)
Main responsibilities include:
Lead small projects utilizing change control systems, establishing, and managing project schedules and timelines. Determine project resource requirements and works with stakeholders.
Develop and execute change control including change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
Create and update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation. Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale. Provide technical support to manufacturing for problems and issues.Qualifications:
Bachelor's degree in an engineering, scientific, or related field is required. 2+ years of experience with change control within the manufacturing industry is required (biological/pharmaceutical/chemical industry preferred). Strong understanding of project management is highly preferred. Familiarity with aseptic vaccine manufacturing operations or equipment is a plus
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