Manufacturing Quality Specialist (2nd Shift)
Eurofins Agroscience Services North Carolina
Eurofins seeks a Manufacturing Quality Specialist for second shift oligonucleotide manufacturing in Louisville, KY. The role ensures product quality and regulatory compliance through process audits, nonconformance management, and continuous improvement initiatives across ISO 13485, ISO 9001, and 21 CFR 820 standards.
Responsibilities
- Investigate customer complaints and support product return management with proper documentation
- Perform manufacturing process audits for risk mitigation and regulatory compliance
- Identify and manage nonconformances, lead root cause analysis, and oversee CAPA resolution
- Monitor manufacturing KPIs and generate performance reports for management review
- Collaborate with production and engineering teams on process improvements and equipment validation
Requirements
- Bachelor's degree in engineering, life sciences, chemistry, or related field
- Minimum 3 years quality assurance or manufacturing quality control in regulated industry
- Working knowledge of 21 CFR 820, ISO 9001, and ISO 13485
- Experience with quality audits, nonconformance management, and root cause analysis
- Strong problem-solving skills and ability to lead CAPA initiatives
- Excellent written and verbal communication with cross-functional collaboration ability
Vacancy posted 2 days ago
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