Senior Specialist Quality Assurance Job at Merck, Delaware, OH

  • Merck
  • Delaware, OH

Job Description

Senior Specialist responsible for quality oversight of GMP computerized systems and digital infrastructure across manufacturing, packaging, and laboratory operations at a pharmaceutical facility. Will ensure compliance with regulatory requirements, manage system validation throughout their lifecycle, and collaborate with cross-functional stakeholders to maintain data integrity and product quality.

Responsibilities

  • Assess and remediate legacy computerized systems while evaluating and implementing new GxP-enabled solutions
  • Provide independent quality approval of validation documentation, protocols, and system changes throughout lifecycle
  • Review and verify compliance activities related to computerized systems are in place and effective
  • Support regulatory inspections and audit activities, respond to findings, and drive resolution of non-conformance
  • Mentor junior team members and promote GxP awareness and continuous improvement culture

Requirements

  • Bachelor's degree in Science, Information Technology, Engineering, or equivalent
  • Minimum 5 years regulated pharmaceutical manufacturing experience
  • At least 3 years delivering validated IT solutions or application support in regulated environment
  • Strong knowledge of FDA/EU/ICH regulations, 21 CFR Part 11, 210, 211, and 820
  • Extensive knowledge of computerized system validation and compliance principles
  • Hands-on experience with automated systems in pharmaceutical manufacturing or laboratory operations
  • Practical experience implementing quality systems in GMP environments

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