Quality Control Technician

The Quality Control (QC) Compliance Investigator II will assist the Laboratory Manager in advancing and closing QC related investigations. Strong technical writing skills are required with flow cytometry and ELISA experience. Experience in a CAR-T or TIL environment is a plus.The ideal candidate will have experience working in a GMP-regulated laboratory with knowledge of writing investigations but is not required. Essential Functions and ResponsibilitiesAssists Lab Support Manager and other investigators with responses to audits, deviations, out of specificationlab investigations, and correctivepreventative actions (CAPA). Work cross-functionally to support deviations and Out of Specification investigations with an emphasis on analytical assays (flow cytometry, ELISA, and other cell-based assays) and Microbiology assays.Gather data in support of deviations and maintain a trending database of applicable metrics.Revise Quality documents in support of deviation mitigation andor CAPAs.Other responsibilities as determined. Required Education, Skills, and KnowledgeBachelor's degree in a relevant discipline (biological sciences or equivalent)1-5 years of experience in the biopharmaceutical industry within a cGMP Quality Control roleBasic knowledge of biological drug development with respect to Quality ControlExtremely detail-oriented with strong analytical, written, and verbal communication skillsDemonstrate sense of urgency; ability to recognize time sensitivityFlexible and adaptable style with an eagerness to take on challenges Preferred Education, Skills, and KnowledgeExperience with cell andor gene therapy productsGMP regulated laboratory experienceKnowledge of investigation writingSalary Range-$40-45hr

Created: 2024-10-28