Manufacturing Quality Specialist - CAPA & Process Improvement

Eurofins Genomics Americas; Louisville (KY); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical, dental, vision

Life and disability insurance

401(k) with company match

Paid vacation & holidays

Job summary

Eurofins USA Genomic Services seeks a Manufacturing Quality Specialist to ensure quality and regulatory compliance across the oligonucleotide manufacturing process per ISO 13485, ISO 9001 and 21 CFR 820. You will implement process controls, audits, CAPA, and continuous improvements in a fast-paced production environment.

Work with cross-functional teams to uphold product standards, address nonconformances, generate KPI reports, and support QMS tasks and documentation control.

Qualifications

• Bachelor’s degree in engineering, life sciences, chemistry, or related field.
• Minimum 3 years of experience in quality assurance or manufacturing quality control in a 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, leadership of CAPA initiatives, and cross-functional collaboration.

Responsibilities

• Lead QA activities and ensure compliance across oligonucleotide manufacturing.
• Perform process audits and implement corrective actions.
• Support NC/CAPA management and root cause analysis.
• Collaborate with production and engineering to drive continuous improvement.
• Provide training to staff on quality standards and procedures.
• Maintain documentation and participate in QMS tasks.
• Monitor KPIs and generate manufacturing process reports.
• Support change management and document control reviews.
• Ensure regulatory requirements are met (ISO 13485, 21 CFR 820).

Job description

Eurofins USA Genomic Services seeks a Manufacturing Quality Specialist to ensure quality and regulatory compliance across the oligonucleotide manufacturing process per ISO 13485, ISO 9001 and 21 CFR 820. You will implement process controls, audits, CAPA, and continuous improvements in a fast-paced production environment.

Work with cross-functional teams to uphold product standards, address nonconformances, generate KPI reports, and support QMS tasks and documentation control.