What are the responsibilities and job description for the Change Control Specialist position at Eurofins USA 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
Qualifications
Additional Information
Eurofins is a M / F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
