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

Qualifications

• Associates degree with 1-2 years, or Bachelor of Science with 0-1, or High School Diploma with 8 years of relevant experience.
• Minimum of 1-2 years GMP experience
• Knowledge of pharmaceutical supply chain or QA experience preferred
• 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

Additional Information

• Position is full-time, Monday-Friday, from 8:00 AM - 5:00 PM.

• overtime as needed

• Candidates currently living within a commutable distance of Durham, NC are encouraged to apply.

• 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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• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.