Evening Shop Floor QA Lead – Biotech Drug Product

Merck & Co.; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Merck & Co. in Durham, NC seeks a Quality Assurance Manager to direct Shop Floor QA on the second shift and oversee end-to-end QA support for Production, Drug Substance, and Drug Product.

The role emphasizes cGMP compliance, environmental monitoring, and ongoing readiness for commercial production. Ideal applicants have aseptic manufacturing experience, strong leadership skills, and a track record of decision-making in regulated environments, with the ability to balance multiple priorities and

Qualifications

• ASEPTIC manufacturing experience or equivalent clean room exposure.
• Experience leading a production-support QA team and shift-based management.
• Solid knowledge of cGMPs, regulations, and quality management systems.
• Decision making, problem solving, and strong communication skills.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Direct the Shop Floor Quality Assurance team on the second shift.
• Provide end-to-end QA support for Production, Drug Substance, and Drug Product during project lifecycle.
• Ensure compliance with cGMP, regulatory requirements, and the Quality Management System.
• Lead deviation management and incident investigations with CAPA coordination.
• Support site safety and quality culture and escalate issues as needed.

Skills

People management

cGMP knowledge

Regulatory compliance

Quality systems

Education

Bachelor's degree in Chemical Engineering

Master's degree in Chemical Engineering

Job description

Merck & Co. in Durham, NC seeks a Quality Assurance Manager to direct Shop Floor QA on the second shift and oversee end-to-end QA support for Production, Drug Substance, and Drug Product.

The role emphasizes cGMP compliance, environmental monitoring, and ongoing readiness for commercial production. Ideal applicants have aseptic manufacturing experience, strong leadership skills, and a track record of decision-making in regulated environments, with the ability to balance multiple priorities and