Quality Assurance Technician

EurofinsDurham, NC
Onsite

About The Position

The Quality Assurance Technician is responsible for collecting details from cross-functional departments to author change controls for components and raw materials. This role involves entering change controls into an electronic system (QTS), routing them for assessments and approvals, and tracking their completion. The technician will also manage new enrollment tasks, extend due dates as needed, and ensure adherence to site SOPs, cGMPs, and safety standards related to production activities in the manufacturing facilities.

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

  • 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

Benefits

  • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
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