Quality Assurance Technician

Eurofins USA PSS Insourcing Solutions•Durham, NC

10h•Onsite

About The Position

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.

Requirements

High School Diploma or Bachelor's degree in a scientific or engineering discipline or similar.
Minimum of 1-2 years GMP experience.
Strong computer skills; specifically Excel and SAP.
Organization/project management skills.
Able to work both independently and as a member of a cross-functional project team in a fast-paced environment.
Authorization to work in the United States indefinitely without restriction or sponsorship.
Valid driver’s license and personal transportation.

Nice To Haves

Knowledge of pharmaceutical supply chain or QA experience preferred.

Responsibilities

Author change controls for components and raw materials by collecting details from cross-functional departments.
Enter change controls into electronic system (QTS) and route them for assessments.
Track and project manage the completion of assessments.
Route change controls for approvals.
Track and project manage approvals.
Track task completion associated with approved change controls 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 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.