Quality Lab Ops Manager - Micro & Environmental Monitoring

Merck

North Carolina

Sur place

USD 90 000 - 120 000

Plein temps

Il y a 3 jours
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Résumé du poste

Merck in Durham, North Carolina, seeks a Laboratory Operations Manager to lead a team of Environmental Monitoring analysts, overseeing routine sampling, testing, start-up and method transfer activities in a GMP environment.

You will report to the Associate Director, Laboratory Operations, manage regulatory compliance, equipment qualification, and collaborate across sites to ensure timely, compliant testing and data integrity.

Qualifications

  • Experience leading environmental monitoring programs in GMP environment.
  • Author/review SOPs, change controls, and investigations for lab methods.
  • Strong cross-functional collaboration and regulatory compliance knowledge.

Responsabilités

  • Author/review technical documents, SOPs, change controls, and investigations for laboratory methods.
  • Troubleshoot laboratory process and equipment issues.
  • Sample management.
  • Plan and execute tests to meet delivery timelines.
  • Provide support during audits and inspections.
  • Collaborate with Durham Laboratory Compliance to ensure regulatory adherence.
  • Support Manufacturing Division initiatives.
  • Additional project and routine testing support as required.
  • Other duties as requested by management.

Description du poste

Merck in Durham, North Carolina, seeks a Laboratory Operations Manager to lead a team of Environmental Monitoring analysts, overseeing routine sampling, testing, start-up and method transfer activities in a GMP environment.

You will report to the Associate Director, Laboratory Operations, manage regulatory compliance, equipment qualification, and collaborate across sites to ensure timely, compliant testing and data integrity.

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