Quality Operations Lab Manager - Environmental Monitoring

Merck & Co.; Durham (NC); On-site; USD 96,000 - 151,000; Full time

Job summary

Merck & Co. in Durham, NC, seeks a Quality Operations Laboratory Manager to lead a team of Environmental Monitoring analysts and oversee routine sampling, testing, and method transfer activities.

The role ensures GMP compliance across internal manufacturing facilities and external partners, driving timely, compliant testing operations. The position reports to the Associate Director, Laboratory Operations and emphasizes cross-functional collaboration, project leadership, and regulatory readiness

Qualifications

• B.S. or M.S. in Biological Sciences with a minimum of 5 years of laboratory experience.
• Experience with execution and trouble-shooting of microbiological testing.
• Experience in Environmental Monitoring, including sampling, testing, and reporting.
• Experience with aseptic handling techniques.
• Technical writing skills and GMP laboratory experience.

Responsibilities

• Lead Environmental Monitoring activities and laboratory testing in Durham.
• Coordinate method transfer/validation projects with internal sites and external partners.
• Support cGMP compliance, audits, and regulatory inspections.
• Develop and review SOPs, change controls, and investigations for lab methods.
• Manage sample handling, testing scheduling, and delivery timelines.

Skills

Microbiological testing

Environmental Monitoring

Aseptic handling

Technical writing

GMP compliance

Education

B.S./M.S. in Biological Sciences

Job description

Merck & Co. in Durham, NC, seeks a Quality Operations Laboratory Manager to lead a team of Environmental Monitoring analysts and oversee routine sampling, testing, and method transfer activities.

The role ensures GMP compliance across internal manufacturing facilities and external partners, driving timely, compliant testing operations. The position reports to the Associate Director, Laboratory Operations and emphasizes cross-functional collaboration, project leadership, and regulatory readiness