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Quality Control Investigation Expert

2 months ago

Baltimore, Maryland, United States Intellectt Inc Full time

Position: Deviation Investigator

Company: Intellectt Inc

Role Overview:

The Deviation Investigator will be responsible for a thorough examination of all project and system outputs, which encompass:

  • Master Batch Records
  • Plans and specifications
  • Test protocols and scripts
  • Execution deliverables and summary reports
  • Change controls

Additionally, the role involves assessing operational and administrative procedures of systems to verify their adequacy.

Key Responsibilities:

  • Documenting any instances of non-compliance.
  • Contributing to strategies for remediation efforts.
  • Recording remediation activities.
  • Assisting in the evaluation of remediation efforts.
  • Carrying out other assigned tasks as necessary.

Qualifications:

The ideal candidate will possess:

  • A Bachelor’s degree in chemical, biomedical, or biochemical engineering, biological sciences, or a related field/experience.
  • Between 2 to 10 years of relevant experience in a cGMP environment.
  • A solid understanding of cGMP manufacturing along with regulatory standards for biotechnology, pharmaceuticals, and medical devices.
  • Experience in quality assurance and remediation activities.
  • Familiarity with reviewing Master Batch Records and validation documentation.
  • Proficiency in documenting remediation processes.