2nd Shift Quality Assurance Specialist - Manufacturing

Eurofins; Louisville (KY); Sur place; USD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical, dental & vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Résumé du poste

Eurofins USA Genomic Services is seeking a Manufacturing Quality Specialist for the 2nd shift to ensure product quality and regulatory compliance across the oligonucleotide manufacturing process, aligned with ISO 13485, ISO 9001 and 21 CFR 820.

You will lead audits, CAPA, nonconformances, and cross-functional training, partnering with production and engineering to drive continuous improvements while maintaining stringent regulatory standards.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, Chemistry, or related field; a Master’s degree is a plus.
• Minimum of 3 years of experience in quality assurance or manufacturing quality control within a regulated industry (pharmaceutical, medical devices, or food manufacturing preferred).
• 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.
• Excellent attention to detail and ability to work in a fast-paced environment.
• Strong communication skills, both written and verbal, and the ability to work collaboratively with cross-functional teams.

Responsabilités

• Provide support for customer complaints related to product quality and collaborate with cross-functional teams for timely solutions.
• Serve as back-up QC technician and perform Final QC checks on VIP and Special Project orders.
• Perform regular manufacturing process audits for risk mitigation, regulatory compliance, and continuous improvement.
• Collaborate with production and engineering to identify and implement process improvements.
• Identify, document, and manage nonconformances; lead root cause analyses and CAPA actions.
• Monitor KPIs and generate KPI reports for management review.
• Support QMS tasks such as Document Control, Training, and Change Management; promote Good Documentation Practices.
• Provide training to production staff on quality standards and procedures.

Connaissances

Quality Assurance

Quality Control

CAPA

Documentation

Cross-functional collaboration

Regulatory compliance

Root cause analysis

Audits

Formation

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

Master’s degree is a plus

Outils

Quality Management Software

Risk assessment tools

Description du poste

Eurofins USA Genomic Services is seeking a Manufacturing Quality Specialist for the 2nd shift to ensure product quality and regulatory compliance across the oligonucleotide manufacturing process, aligned with ISO 13485, ISO 9001 and 21 CFR 820.

You will lead audits, CAPA, nonconformances, and cross-functional training, partnering with production and engineering to drive continuous improvements while maintaining stringent regulatory standards.