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Technical Operations Change Control Specialist
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Full-time
- Arcadis DPS is looking for a Technical Operations Change Controls Specialist for a client in Boston, MA.
- Work with technical SMEs (Regulatory, Engineering and Facilities, Manufacturing Science and Technology, Process Development, Supply Chain, Validation) to ensure the appropriate stakeholders are involved in the assessment of the change control and completion of the tasks
- Scope of change controls includes but not limited to: Introduction of new process equipment, changes to existing process equipment, technical transfer of new process from Process Development to Manufacturing, tech transfer between manufacturing sites, changes to existing process, scale-ups, changes to Raw Materials, introduction of new programs/strategies.
- Preferably as a manufacturing specialist, MSAT/PD, process engineering, or QA specialist
- Experience writing change controls for biotech (biologics preferred) in an electronic Quality Management System such as Veeva or Trackwise
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