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Quality Assurance/Investigation Specialist
4 weeks ago
Title: Deviation Investigator
Location: Baltimore, MD
Duration: 6+ Months
Job Description:
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.
Requirements:
BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
2-10 years 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.
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