Quality Assurance Specialist - Change Control
Quality Assurance Specialist - Change Control
Posted on :
22-08-2025
Employer Active
1 Vacancy
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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 :
- Bachelors degree in a scientific or engineering discipline or similar with a 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 drivers license and personal transportation
Additional Information :
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 holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
Key Skills
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