Quality Lab Operations Manager, Environmental Monitoring

MSD; North Carolina; On-site; USD 96,000 - 151,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Job summary

MSD in Durham, NC seeks a Laboratory Operations Manager to lead a team of Environmental Monitoring analysts, oversee microbiological testing and method transfer, and ensure cGMP regulatory compliance. The role partners with internal sites and external partners to deliver compliant, reliable testing in a global manufacturing network.

The candidate will report to the Associate Director, Laboratory Operations and drive start-up testing, device qualification, trending, and investigations while

Qualifications

• Experience with execution and troubleshooting of microbiological testing.
• Experience in Environmental Monitoring, including sampling, testing, and reporting.
• Experience with aseptic handling techniques.
• Technical writing skills.
• Previous GMP laboratory experience.

Responsibilities

• Lead Environmental Monitoring and routine testing activities.
• Coordinate method transfer/validation and instrument qualification.
• Ensure regulatory compliance and support audits/inspections.
• Manage laboratory staff and collaboration with cross-functional teams.
• Support start-up testing for new facilities and utilities.

Skills

Microbiological testing

Environmental Monitoring

Aseptic Handling

Technical writing

GMP Laboratory

Education

B.S. or M.S. in Biological Sciences

Job description

MSD in Durham, NC seeks a Laboratory Operations Manager to lead a team of Environmental Monitoring analysts, oversee microbiological testing and method transfer, and ensure cGMP regulatory compliance. The role partners with internal sites and external partners to deliver compliant, reliable testing in a global manufacturing network.

The candidate will report to the Associate Director, Laboratory Operations and drive start-up testing, device qualification, trending, and investigations while