Senior Specialist, Quality Control

Merck & Co., Inc.

Equipment qualification in gmp environment
Computerized systems validation experience
Laboratory system lifecycle management
The role ensures high standards of quality and compliance within a global manufacturing network committed to delivering reliable supply to patients

Job Summary

  • The role ensures high standards of quality and compliance within a global manufacturing network committed to delivering reliable supply to patients.
  • Responsibilities include leading laboratory system lifecycle management, risk-based qualification, and root cause analysis for quality notifications.
  • Candidates must act as a Subject-Matter-Expert, providing guidance to team members and supporting audit requirements.

Matching Summary

The role ensures high standards of quality and compliance within a global manufacturing network committed to delivering reliable supply to patients.

Skills & Requirements

Must-have

  • Equipment Qualification in GMP environment
  • Computerized Systems Validation experience
  • Laboratory system lifecycle management
  • Root cause analysis execution
  • GxP regulatory compliance knowledge

Nice-to-have

  • LabX or Empower software experience
  • System Development Lifecycle (SDLC) expertise
  • Cross-functional team leadership skills
  • Continuous improvement mindset
  • Strategic critical thinking abilities

Key Requirements

  • Minimum 6 years applied professional work experience
  • Degree in relevant scientific or technical discipline
  • Experience in GMP regulated QC Laboratory or Lab Systems Support

Work Rights

Not specified

Tailored Resume

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