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Jobs / Quality Assurance Specialist in United States of America
27 days ago
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Merck KGaA·27 days ago
27 days ago

Quality Assurance Specialist 3 - Compliance and Audits

Rockville, United States of AmericaFull-timeMid · 2-5 years

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About this role

We are looking for a Quality Specialist 3 – Compliance and Audits to provide independent quality oversight within a GMP/GLP-regulated laboratory environment. Lead audits, ensure regulatory compliance, and support continuous improvement. Ideal for candidates with experience in quality assurance and regulatory compliance.

Skills

  • gmp compliance
  • glp compliance
  • internal audit
  • root cause analysis
  • capa management
  • inspection readiness
  • audit support
  • regulatory submissions
  • supplier audit
  • haccp
  • fmea
  • quality management systems
  • continuous improvement
  • quality metrics analysis
  • fda 21 cfr parts 58
  • eu gmp requirements
  • ich q9/q10
  • sop review
  • change control
  • risk assessment
  • client quality agreements
  • stakeholder communication
  • analytical skills
  • problem solving
H1B sponsor likely
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