Change Control Specialist
Change Control Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The purpose of this role is to author technical documents to change current processes for drug development.
- Collect details from crossfunctional 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 :
- Bachelors 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 SOPs 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 crossfunctional team in a fastpaced environment
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Valid drivers license and personal transportation
Additional Information :
- This is a nonlab basedrole all duties will take place in an office environment.
- Position is fulltime 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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
