Quality Specialist 4 – Vaccine

Ampcus Inc.
Published
June 4, 2021
Location
Atlanta, GA
Category
Job Type

Description

Description:

Specialist IV – Quality

NCL/OMCL Process Support

Must be local to Northern America region but will be 100% virtual

Key Responsibilities:

Maintain high-level oversight of all Drug Substance (DS) and Drug Product (DP) lots manufactured throughout the production network

Liaise with samples coordinators at external manufacturers to schedule and execute samples shipments to NCL/OMCLs (National Control Laboratories/Official Medicines Control Laboratories)

Schedule shipping route verification studies and review/approve shipping route verification reports to validate shipping lanes across the network in timely manner

Should samples arrive with alarmed temperature monitor, advise on product disposition

Ensure samples are tracked in eLIMS accurately and in a timely manner

Lead process improvement initiatives to streamline samples sending/receipt processes

Manage process for sending/receiving backup samples as needed

Provide support documentation preparation and submission to health agencies as needed

Complete and pass all applicable training required for access to quality and information management systems (i.e. ETS Trackwise, eLIMS etc.)

Complete and pass all applicable Good Manufacturing Practice training and general quality management training

Learning and remaining current with local regulations, guidelines and quality practices associated with the vaccines industry is required

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