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Form of workJob Description
Location: Gaithersburg, MD
We are currently seeking junior or masters-level (rising included) students working towards a degree in mechanical engineering, chemical engineering, bioengineering, or a related field for a 10-12 week internship during the summer of 2024.
Primary Duties:
Review the existing risk management document for commercial pre-filled syringe (PFS), accessorized pre-filled syringe (APFS), and autoinjector (AI) combination products and obtain relevant information to product’s defects and received complaints.
Established new mapping tables between risk management files and product defects for periodic risk review reporting, a FDA requirement, for PFS and APFS combination products recently launched to the market.
Update the existing mapping tables between risk management files and product defect for periodic risk review reporting for on-market APFS and AI combination products.
Deliver the outcome of the performed activities as in a form of presentation and/or poster to Biologics Operation Team.
Learn and practice cross-functional teamwork environment.
