2nd-Shift Manufacturing Quality Specialist

Eurofin; Louisville (KY); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Excellent full-time benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins Scientific is seeking a Manufacturing Quality Specialist on the 2nd shift to ensure product quality and regulatory compliance in the oligonucleotide manufacturing environment. You will implement process controls, conduct audits, and support CAPA activities across cross-functional teams.

The role emphasizes risk assessment, continuous improvement, and strong documentation practices in a fast-paced production setting, with a focus on ISO 13485 and 21 CFR 820 standards.

Qualifications

• Minimum of 3 years of experience in quality assurance or manufacturing quality control within a regulated industry.
• Working knowledge of 21 CFR 820, ISO 9001, and ISO 13485.
• Experience with quality audits, nonconformance management, and root cause analysis techniques.
• Strong problem-solving skills and ability to lead CAPA initiatives.
• Excellent attention to detail and ability to work in a fast-paced environment.

Responsibilities

• Provide support for customer complaints related to product quality, investigate issues, and collaborate with cross-functional teams.
• Support management and testing of returned products, ensuring proper documentation and resolution of quality concerns.
• Serve as back-up QC technician and perform final QC checks on VIP and Special Project orders.
• Perform regular audits of manufacturing processes for risk mitigation and regulatory compliance.
• Collaborate with production and engineering to identify and implement continuous improvement initiatives.
• Lead CAPA investigations, document nonconformances, and verify effectiveness of actions.
• Monitor KPIs and generate KPI reports for management, highlighting trends and corrective actions.
• Support QMS tasks such as Document Control Reviews, Training Module Reviews, and Change Management.

Education

Bachelor’s degree in engineering, Life Sciences, Chemistry, or a related field

Master’s degree is a plus

Job description

Eurofins Scientific is seeking a Manufacturing Quality Specialist on the 2nd shift to ensure product quality and regulatory compliance in the oligonucleotide manufacturing environment. You will implement process controls, conduct audits, and support CAPA activities across cross-functional teams.

The role emphasizes risk assessment, continuous improvement, and strong documentation practices in a fast-paced production setting, with a focus on ISO 13485 and 21 CFR 820 standards.