Job Title: Senior Manufacturing Quality Engineer Pharmaceutical
Location: Lexington, KY
Duration : 12 Months
Position Overview
The Senior Manufacturing Quality Engineer is responsible for ensuring that pharmaceutical manufacturing processes consistently meet quality, safety, and regulatory standards. This is a hands-on, shop-floor-focused role involving real-time production monitoring, defect investigation, and implementation of corrective actions. The role requires strong expertise in root cause analysis, CAPA, and statistical process control to drive continuous improvement.
Shift Options (Multiple Available)
Monday Thursday: 7:00 AM 5:15 PM (4 x 10-hour shifts)
Monday Thursday: 5:15 PM 3:30 AM (4 x 10-hour shifts)
Friday Sunday: 6:00 AM 6:00 PM (3 x 12-hour shifts)
Friday Sunday: 6:00 PM 6:00 AM (3 x 12-hour shifts)
Key Responsibilities
Perform root cause analysis (RCA) on quality issues and implement effective corrective and preventive actions (CAPA)
Monitor manufacturing processes on the production floor to ensure compliance with specifications and quality standards
Collaborate with cross-functional teams including production, engineering, and quality to resolve defects and improve processes
Ensure compliance with regulatory and quality standards such as ISO 9001 and applicable industry requirements
Develop, review, and maintain Standard Operating Procedures (SOPs) and quality documentation
Conduct inspections, testing, and validation activities for raw materials and finished products
Support internal and external audits and track quality metrics for continuous improvement
Drive process optimization using statistical process control (SPC) and quality tools
Required Qualifications
Experience in a manufacturing quality environment
Strong understanding of quality systems, methodologies, and tools (RCA, CAPA, SPC)
Experience working within ISO 9001 or similar quality frameworks
Bachelor's degree in Engineering or a related technical field
Excellent analytical, problem-solving, and decision-making skills
Proficiency in documentation, database systems, and quality tracking tools
Preferred Qualifications
Pharmaceutical or regulated industry experience
Certifications such as Six Sigma, CQE (Certified Quality Engineer), or CQA (Certified Quality Auditor)
Knowledge of defect management systems and version control processes
Familiarity with Agile/Scrum methodologies in quality environments
Multilingual communication skills
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