Manufacturing Quality Specialist

Job Description

Manufacturing Quality Specialist ensures 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 Support:

• Provide support to customer complaints related to product quality, investigating issues, and collaborating with cross-functional team to provide timely solutions.
• Provide support to the management and testing of returned products, ensuring proper documentation and resolution of any quality concerns.

2. Quality Control Support

• Serve as a back-up QC technician as needed.
• Perform Final QC checks on VIP and Special Project orders.

3. 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.

4. 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.

5. 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.

6. Quality Metrics and Reporting

• 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.

7. QMS Support

• Supports QMS tasks as assigned, such as Document Control Reviews, Training Module Reviews, Change Management, etc.
• Champions Good Documentation Practices through daily audits.

8. 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 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.

Desired 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.

Additional Information

Schedule:

• Tuesday to Saturday (3 PM to 12 AM)

What we offer:

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

Eurofins USA Genomic Services is a Disabled and Veteran Equal Employment Opportunity employer.