Manufacturing Quality Specialist (2nd Shift)

Eurofins USA Genomic Services•Louisville, KY

About The Position

The Manufacturing Quality Specialist ensures the quality and compliance of products throughout the oligonucleotide manufacturing process in accordance with ISO 13485, ISO 9001, and 21 CFR 820. The role focuses on implementing process control systems, conducting process audits, and supporting improvements in production. The specialist works with cross-functional teams to uphold product standards, address nonconformities, and meet regulatory requirements. The position supports customer complaints and returned-product management, provides backup quality control support, and performs final quality checks for VIP and Special Project orders. It also supports quality management system tasks, staff training, quality metrics and reporting, and manufacturing process audits and improvements.

Requirements

Bachelor’s degree in engineering, life sciences, chemistry, or a related field.
At least 3 years of experience in quality assurance or manufacturing quality control in a regulated industry.
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 ability to lead CAPA initiatives.
Excellent attention to detail and ability to work in a fast-paced environment.
Strong written and verbal communication skills and ability to collaborate with cross-functional teams.

Nice To Haves

Master’s degree.
Experience in pharmaceutical, medical device, or food manufacturing.
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

Support investigations of customer complaints related to product quality and collaborate with cross-functional teams to provide timely solutions.
Support the management and testing of returned products, ensuring appropriate documentation and resolution of quality concerns.
Serve as a backup QC technician as needed and perform final QC checks on VIP and Special Project orders.
Audit manufacturing processes for risk mitigation, regulatory compliance, and continuous improvement; implement corrective actions and ensure findings are resolved on time.
Collaborate with production and engineering teams on continuous improvement initiatives, process optimization, and equipment validation.
Identify, document, and manage manufacturing nonconformances; lead investigations and root cause analysis.
Manage CAPAs, verify the effectiveness of implemented actions within the required timeframe, and help prevent recurrence of issues.
Monitor manufacturing process KPIs and prepare reports for management that highlight trends, improvement areas, and corrective actions.
Support QMS tasks such as document control reviews, training module reviews, and change management.
Champion Good Documentation Practices through daily audits.
Train production staff on quality standards, procedures, and best practices, and provide guidance on quality-related issues.
Perform quality control testing and final product documentation reviews as needed.