Seqirus Holly Springs, NC, USA
Job Purpose: Responsible for providing quality system support to Fill Finish manufacturing areas within the Seqirus Vaccines manufacturing facility located in Holly Springs, NC. Responsible for Deviations and investigations using Root Cause analysis and technical writing to complete reports for audit purposes. *Level will be determined by years of experience Major Accountabilities: Owns deviations and writes product impact assessments. Leads cross functional investigation teams in root cause analysis Creates and executes CAPA plans to reduce the likelihood of reoccurrence. Writes SOPs and batch records to support expansion activities Issues SOPs and Batch Records to the production floor Owns change controls including site wide change controls. Writes Biological Product Deviation Report for submission to the FDA. Performs Product Technical Compliant and Adverse Event investigations. Provides technical support with multiple unit operations. Identifies...
Manufacturing Quality Assurance & Control