Quality Operations Laboratory Manager

Merck seeks a Quality Operations Laboratory Manager to lead Environmental Monitoring analysts at the Durham manufacturing site. The role involves routine sampling, testing, method transfers, and facility start-up activities while ensuring cGMP compliance and regulatory requirements across microbiological and environmental testing operations.

Responsibilities

• Lead team of Environmental Monitoring analysts in routine sampling and testing activities
• Author and review technical documents, SOPs, change controls, and investigation reports
• Execute method transfers, facility start-ups, and equipment qualification with cross-functional teams
• Troubleshoot laboratory processes and equipment issues; manage sample handling and test execution
• Support regulatory audits, inspections, and product license documentation requirements

Requirements

• Bachelor's or Master's degree in Biological Sciences
• Minimum 5 years of laboratory experience
• Microbiological testing execution and troubleshooting expertise
• Environmental Monitoring sampling, testing, and reporting experience
• Aseptic handling techniques proficiency
• Technical writing and GMP laboratory experience
• Leadership experience preferred