Manufacturing Quality Specialist (2nd Shift)

Eurofins•Louisville, KY

5d•Hybrid

About The Position

The 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.

Requirements

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

Nice To Haves

Master’s degree is a plus.
Proficiency with quality management software and tools.
Familiarity with manufacturing processes and equipment.
Familiarity with risk management tools
Strong organizational and time-management abilities.

Responsibilities

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.
Serve as a back-up QC technician as needed.
Perform Final QC checks on VIP and Special Project orders.
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.
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.
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.
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.
Supports QMS tasks as assigned, such as Document Control Reviews, Training Module Reviews, Change Management, etc.
Champions 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, providing guidance on quality-related issues.
Perform quality control testing and final product documentation review as needed.