Manufacturing Quality Specialist (2nd Shift)

About the role

Eurofins Scientific is an international life sciences company providing analytical testing services to ensure the safety, authenticity, and accuracy of products across multiple industries. As a Manufacturing Quality Specialist, you will ensure the quality and compliance of oligonucleotide manufacturing processes per ISO 13485, ISO 9001, and 21 CFR 820. This role focuses on implementing process control systems, conducting audits, and supporting process improvements in collaboration with cross-functional teams.

Responsibilities

• Support customer complaints and product returns by investigating quality issues and collaborating with teams to provide timely solutions. Manage and test returned products, ensuring proper documentation and resolution of quality concerns.
• Serve as a backup QC technician and perform final QC checks on VIP and Special Project orders.
• Perform regular audits of manufacturing processes to mitigate risks, ensure regulatory compliance, and drive continuous improvement. Implement corrective actions based on audit findings.
• Collaborate with production and engineering teams to identify and implement continuous improvement initiatives aimed at enhancing product quality and efficiency. Participate in process optimization and equipment validation efforts.
• Identify, document, and manage nonconformances during manufacturing. Lead investigations, conduct root cause analysis, and manage Corrective and Preventive Actions (CAPA) to resolve issues and prevent recurrence.
• Monitor key performance indicators (KPIs) to measure manufacturing process control effectiveness. Generate and present KPI reports to management, highlighting trends, areas for improvement, and corrective actions.
• Support Quality Management System (QMS) tasks such as document control reviews, training module reviews, and change management. Champion Good Documentation Practices through daily audits.
• Provide training to production staff on quality standards, procedures, and best practices. Act as a resource for manufacturing teams, offering guidance on quality-related issues and performing QC testing and final product documentation reviews as needed.

Requirements

• Bachelor’s degree in engineering, Life Sciences, Chemistry, or a 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 (e.g., pharmaceutical, medical devices, or food manufacturing).
• 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 collaborate with cross-functional teams.

Skills

• Proficiency with quality management software and tools.
• Familiarity with manufacturing processes and equipment.
• Familiarity with risk management tools.
• Strong organizational and time-management abilities.

Work Environment

This role may involve working in both office and manufacturing environments.

Schedule

Tuesday to Saturday (3 PM to 12 AM).

Benefits

• Excellent full-time benefits including comprehensive medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.