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

• Bachelor's degree in a scientific or engineering discipline or similar, with a minimum of 1 year GMP experience
• Lab experience is beneficial, but not required.
• Experience with changing lab processes, SOP's, procedures, etc.
• Knowledge of pharmaceutical supply chain or QA experience preferred
• Strong computer skills; specifically Excel and SAP
• Able to work both independently and as a member of a cross-functional 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

• This is a non-lab based-role - all duties will take place in an office environment.
• Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of Sanford, 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 holiday

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