Quality Operations Lab Manager (Microbiology)

MSD; Durham (NC); On-site; USD 96,000 - 151,000; Full time

Job summary

Merck in Durham, NC is seeking a Quality Operations Laboratory Manager to lead Environmental Monitoring analysts and manage microbiological testing and method transfer. The role reports to the Associate Director of Laboratory Operations and spans startup, validation, and routine testing in a cGMP environment.

You will coordinate cross-functional teams, develop documentation, and ensure regulatory readiness across site facilities. Strong leadership and technical writing are essential for success.

Qualifications

• B.S. or M.S. in Biological Sciences with minimum 5 years of lab experience.
• Experience executing and troubleshooting microbiological testing.
• Experience in Environmental Monitoring incl. sampling, testing, reporting.
• Experience with aseptic handling techniques and GMP labs.
• Technical writing skills and regulatory document support.

Responsibilities

• Author/review technical documents, SOPs, change controls, investigations.
• Troubleshoot laboratory processes and equipment as needed.
• Sample management and test method scheduling.
• Plan and execute tests to meet delivery timelines.
• Support during audits and inspections by regulatory bodies.
• Collaborate with Durham Laboratory Compliance and cross-functional teams.

Skills

Analytical Method Transfer

Aseptic Handling

cGMP Regulations

Decision Making

Environmental Monitoring

External Manufacturing

GMP Laboratory

Good Lab Practices

Good Manufacturing Practices

Laboratory Instrumentation

Laboratory Operations

Laboratory Research

Manufacturing Quality Control

Method Development

People Leadership

Pharmaceutical Quality Control

Problem Identification

Process Testing

Product Testing

Professional Integrity

Quality Inspections

Quality Systems Compliance

Regulatory Audits

Regulatory Inspections

Education

Bachelor's or Master's in Biological Sciences

Job description

Merck in Durham, NC is seeking a Quality Operations Laboratory Manager to lead Environmental Monitoring analysts and manage microbiological testing and method transfer. The role reports to the Associate Director of Laboratory Operations and spans startup, validation, and routine testing in a cGMP environment.

You will coordinate cross-functional teams, develop documentation, and ensure regulatory readiness across site facilities. Strong leadership and technical writing are essential for success.