Qc Stability Analyst Iii
CurrentQC Stability analyst III responsible for standing shoulder to shoulder with colleagues as the lead Stability Analyst, accomplishing all day-to-day operations of the stability program, including the review, compilation and digital archiving of 16 years of assay data, from Viral Bank to Commercial Lyophilized Final Drug Product, as well as all new contemporaneous data as it comes in. Daily operations include oversight and management of stability inventory, as well as the scheduling, submission and chain of custody for vaccine drug substance and drug product. I coordinate acquisition of new product from on-site manufacturing teams as well as fill finish operations teams in support of annual regulatory commitments and ad-hoc studies.Ownership of all Stability related deviations, change controls and corrective and preventative actions(CAPA).Primary responsibilities beyond inventory management and QN ownership include the timely receipt of all assay metadata for any stability testing, and the corresponding statistical analysis of stability and release data. JMP data analysis includes Levey Jennings, I-MR, Degradation/Regression of quantitative assay data.Secondary responsibilities include maintaining Capex for stability chambers, identifying and initiating Out of Spec/Out of Trend investigations, and acting as SME during audits.For a brief period I assisted the QC Microbiology team, collecting water, clean steam and other liquid sources used in both upstream and downstream manufacturing. Testing for these include Endotoxin, Bioburden, and others.
