What are the responsibilities and job description for the Deviation Investigators position at Vakula Technologies Inc?
Position: Deviation Investigators
Location: Baltimore MD (100% on-site)
Pay Rate: 20$-25$
Duration of project: 6 months
Requirements
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.
- 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.
