Job Description

Merck seeks a Senior Specialist Quality Assurance to support its Quality Center of Excellence, overseeing commissioning, qualification, and validation of facilities and processes for antibody drug conjugates and potent compounds. The role requires ensuring compliance with cGMP regulations, company policies, and health agency requirements while collaborating across global teams.

Responsibilities

• Direct quality aspects of facility, utility, and equipment commissioning, qualification, and validation activities
• Participate in commissioning, qualification, and validation across manufacturing, packaging, labeling, and laboratory operations
• Collaborate with operations, engineering, IT, and automation stakeholders to provide quality input and facilitate improvements
• Serve as primary Quality contact for ongoing validation and qualification activities including cleaning and utilities qualification
• Provide quality oversight of on-site laboratory operations and support Supplier Quality Management processes

Requirements

• Minimum 5 years in Quality Control, Quality Assurance, or Pharmaceutical/Biological Operations
• At least 2 years commissioning, qualification, and validation experience in regulated environment
• At least 2 years commercial QC Lab experience
• Knowledge of cleaning in place, cleaning out of place, and sanitization procedures
• Proficiency with continuous quality improvement tools such as DMAIC or Lean
• Bachelor's degree in Chemistry, Biology, Microbiology, Engineering, or related discipline
• Strong analytical, problem-solving, and root-cause analysis capabilities

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