Senior Specialist - Quality

Merck & Co., Inc.

Hybrid
10 years experience in change control
Strong knowledge of cgmp regulations
Experience with analytical standards management
The role is responsible for providing functional support for Analytical Standards and Analytical change control activities within a global manufacturing network

Job Summary

  • The role is responsible for providing functional support for Analytical Standards and Analytical change control activities within a global manufacturing network.
  • Candidates must ensure alignment across subject matter experts to implement analytical changes globally while maintaining compliance with current Good Manufacturing Practices.
  • The position requires managing multiple projects simultaneously with competing priorities in a complex business environment involving Small Molecule, Biologics, and Vaccines.

Matching Summary

The role is responsible for providing functional support for Analytical Standards and Analytical change control activities within a global manufacturing network.

Skills & Requirements

Must-have

  • 10 years experience in change control
  • Strong knowledge of cGMP regulations
  • Experience with analytical standards management
  • Ability to manage compendial compliance
  • Document review and quality approval skills

Nice-to-have

  • Superior written and oral communication skills
  • Advanced problem solving and decision making
  • Creative thinking and original concept development
  • Ability to build consensus across stakeholders
  • Proficient computer skills for data analysis

Key Requirements

  • BS degree in life sciences, engineering or related discipline
  • Minimum 10 years applied professional work experience
  • Experience in Change Control, Laboratory Operations, or Quality operations

Work Rights

Not specified

Tailored Resume

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