Manufacturing Quality Specialist - Eurofins Genomics LLC

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

Job Description

We are seeking a dedicated Manufacturing Quality Specialist to ensure the quality and compliance of products throughout the oligonucleotide manufacturing process per ISO 13485, ISO 9001, and 21 CFR 820. This role will focus on implementing process control systems, conducting process audits, and supporting process improvements in the production environment. The Manufacturing Quality Specialist will work closely with cross-functional teams to uphold product standards, address nonconformities, and ensure regulatory requirements are met.

Key Responsibilities:

1. Customer Complaints and Product Returns:

• Address customer complaints related to product quality, investigating issues, and collaborating with cross-functional team to provide timely solutions.
• Manage the return of products, ensuring proper documentation and resolution of any quality concerns.

2. Manufacturing Process Audits:

• Perform regular audits of manufacturing processes for risk mitigation, regulatory compliance, and continuous improvement.
• Implement corrective actions based on audit findings and ensure timely resolution of identified issues.

3. Process Improvement:

• 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 to improve overall manufacturing processes.

4. Nonconformance and CAPA Management:

• Identify, document, and manage nonconformances during the manufacturing process.
• Lead investigations into quality issues and conduct root cause analysis to identify underlying problems.
• Manage Corrective and Preventive Actions (CAPA) to resolve issues and prevent recurrence.
• Verify effectiveness of implemented actions within a given timeframe.

5. Quality Metrics and Reporting

• Develop and monitor key performance indicators (KPIs) to measure the effectiveness of manufacturing process controls.
• Generate and present manufacturing process KPI reports to management, highlighting trends, areas for improvement, and corrective actions.

6. Cross-Functional Support:

• Provide training to production staff on quality standards, procedures, and best practices.
• Act as a resource for manufacturing teams, providing guidance on quality-related issues.
• Perform quality control testing and final product documentation review as needed.

Qualifications

• Education: Bachelor's degree in engineering, Life Sciences, Chemistry, or a related field; a Master's degree is a plus.
• Experience: Minimum of 3years 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-solvi