Quality Assurance Specialist Details

splintpharma - Remote

Employment Type : Full-Time

Quality Assurance Specialist, Client: Novavax - Remote for now Perform hands on ownership of a subset of quality records such as deviations, CAPA, change controls, and OOS investigations.  Act as quality owner of an assigned set of records and work with technical partner to perform robust, compliant investigations, and bring the records to closure. Works independently to gather information and evidence, with guidance from Novavax SMEs, performs and documents investigation and root cause analysis,  uploads all required information to Novavax quality management electronic systems, and bring records to closure.

 

At least 3 years’ experience in quality assurance in the biotechnology or pharmaceutical industry and in-depth experience owning, reviewing, and approving deviations, CAPA, change controls, or OOS investigations. Must be proficient in investigation processes and root cause analysis. A minimum of a Bachelor’s degree in a scientific discipline.

 

Must have vaccine or biologics experience