Change Control Specialist
Eurofins Agroscience Services North Carolina
Eurofins seeks a Change Control Specialist to manage GMP change control processes for laboratory testing operations. The role involves executing analytical changes, leading cross-functional teams, ensuring regulatory compliance, and providing technical expertise on complex quality initiatives in a West Point, PA facility.
Responsibilities
- Execute GMP change control processes and manage analytical change activities for multiple requests
- Serve as Subject Matter Expert for Second Person Review and cross-functional coordination
- Evaluate regulatory, compliance, operational, and technical impacts of proposed laboratory changes
- Lead root cause investigations and resolution of complex quality and compliance issues
- Author technical reports, procedures, and regulatory support documentation
Requirements
- Bachelor's degree in Life Sciences, Biology, Chemistry, Microbiology, or related field
- Minimum 5 years pharmaceutical, biologics, laboratory operations, or GMP quality systems experience
- Proven expertise in change control, investigations, quality systems, and regulatory compliance
- Experience leading complex technical initiatives across multiple departments
- Strong analytical, problem-solving, and leadership capabilities
- Excellent technical writing and stakeholder communication skills
- Authorization to work in United States without sponsorship
Vacancy posted 6 days ago
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