Deviation Investigators

1 month ago


Baltimore, United States Vakulatech Full time
Job DescriptionJob DescriptionPosition: Deviation Investigators
Location: Baltimore MD (100% on-site)
Pay Rate: 20$-25$
Duration of project: 6 months+ Requirements:
  • BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
  • 1+ years of relevant industry experience working in a cGMP environment.
  • Working knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals, and medical devices in your toolbox.
  • Experience quality assurance tasks and remediation actives.
  • Experience reviewing Master Batch Records and validation documents.
  • Experience with documenting remediation activities.

Job Details:
  • Reviewing all project and system deliverables including but not limited to: Master Batch Records, plans, requirements, specifications, test protocols, scripts and associated execution deliverables, summary reports, and change controls
  • Reviewing system operational and administration procedures to ensure they are adequate.
  • Documenting any findings of non-compliance.
  • Assisting with strategy regarding remediation activities.
  • Documenting remediation activities.
  • Assisting with review of remediation activities.
  • Performs other duties as assigned.
Please share the resume to jayanth@vakulatech.com

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