Oligonucleotide Manufacturing Quality Lead

Eurofins Genomics Americas; Louisville (KY); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, Dental, Vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA Genomic Services is seeking a Manufacturing Quality Specialist to ensure quality and compliance of products throughout the oligonucleotide manufacturing process per ISO 13485, ISO 9001, and 21 CFR 820. You will implement process control systems, conduct audits, and support continuous improvements in a fast-paced production environment.

Responsibilities include handling customer quality-related issues, performing audits, leading CAPA initiatives, and mentoring production staff on

Qualifications

• Bachelor’s degree in engineering, Life Sciences, or Chemistry.
• Minimum 3 years of experience in QA 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 techniques.
• Strong problem-solving skills and the ability to lead CAPA initiatives.

Responsibilities

• Perform manufacturing process audits for risk mitigation, regulatory compliance, and continuous improvement.
• Lead investigations into quality issues and manage CAPA actions to prevent recurrence.
• Provide training to production staff on quality standards and procedures.
• Monitor KPIs and generate quality metrics reports for management.
• Supports QMS tasks such as Document Control Reviews and Change Management.
• Perform quality control testing and final product documentation review as needed.

Skills

Quality Assurance

CAPA leadership

Root cause analysis

Cross-functional teamwork

Documentation

Education

Bachelor’s degree

Master’s degree

Tools

Quality management software

Job description

Eurofins USA Genomic Services is seeking a Manufacturing Quality Specialist to ensure quality and compliance of products throughout the oligonucleotide manufacturing process per ISO 13485, ISO 9001, and 21 CFR 820. You will implement process control systems, conduct audits, and support continuous improvements in a fast-paced production environment.

Responsibilities include handling customer quality-related issues, performing audits, leading CAPA initiatives, and mentoring production staff on