Quality Assurance Specialist

Job Description

Collecting details from cross-functional departments to author change controls for components and raw materials

Entering change controls into electronic system (QTS) and routing to departments for assessments

Tracking and project managing the assessment completion

Routing the change control for approvals

Tracking and project managing approvals

Tracking task completion associated with approved change control and working with owners to ensure tasks are completed by assigned due dates

Entering new enrollment tasks into electronic system (QTS) and assigning task owners

Extending 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