QC Analyst III, Analytical - LSA

Execute complex biological, immunological, and cell-based testing using flow cytometry, ELISA, PCR assays, and cell culture to support cGMP release and in-process control. Spearhead analytical method transfers, qualifications, and validation protocols while configuring advanced laboratory instrumentation. Review raw laboratory records, data calculations, and execution logs for accuracy and Good Documentation Practices compliance. Lead comprehensive Out-of-Specification and deviation investigations, author corrective and preventive actions, and manage structured change controls. Develop and sustain standard operating procedures, master forms, and test records. Deliver hands-on training for junior QC personnel and escalate critical laboratory anomalies to management. Requires 3-4+ years of cGMP biomanufacturing experience, a Bachelor's degree in a related science, and proficiency in cell culture and immunophenotyping.