Specialist, Quality Assurance (Second Shift)

Merck seeks a Quality Assurance Specialist for its Durham, North Carolina manufacturing facility on second shift. The role involves providing quality support to pharmaceutical and biologic operations, managing compliance documentation, conducting audits, and leading process improvements across manufacturing activities.

Responsibilities

• Independently manage assigned quality assurance project components and ensure GMP compliance
• Review and approve GMP documentation including batch records, deviation investigations, and cleaning validation
• Provide quality support on aseptic techniques, gowning observations, and environmental monitoring
• Lead shop floor audits to identify and address compliance gaps and housekeeping issues
• Partner with cross-functional teams on change controls, problem-solving, and process improvements

Requirements

• High school diploma or equivalent
• Minimum four years manufacturing, laboratory, or FDA-regulated industry experience
• At least two years GMP or FDA-regulated environment experience
• Knowledge of current good manufacturing practices and FDA regulations
• Strong decision-making, problem-solving, and communication abilities
• Capability to manage multiple priorities in fast-paced environments

Compensation: $87,300-$137,400 base