What are the responsibilities and job description for the Change Control Specialist position at Eurofins PSS Insourcing Solutions?
Job Description
The purpose of this role is to author technical documents to change current processes for drug development.
Collect details from cross-functional departments to author change controls for components and raw materials
Enter change controls into electronic system (QTS) and routing to departments for assessments
Track and project manage the assessment completion
Route change control for approval, track and manage approvals
Track task completion associated with approved change control and work with owners to ensure tasks are completed by assigned due dates
Enter new enrollment tasks into electronic system (QTS) and assign task owners
Extend enrollment due dates when needed
Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities
Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the Clinical Manufacturing department
The purpose of this role is to author technical documents to change current processes for drug development.
Collect details from cross-functional departments to author change controls for components and raw materials
Enter change controls into electronic system (QTS) and routing to departments for assessments
Track and project manage the assessment completion
Route change control for approval, track and manage approvals
Track task completion associated with approved change control and work with owners to ensure tasks are completed by assigned due dates
Enter new enrollment tasks into electronic system (QTS) and assign task owners
Extend enrollment due dates when needed
Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities
Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the Clinical Manufacturing department
