Position Overview:The Senior Quality Control Analyst will be responsible for conducting development, validation, routine testing and GMP review of analytical assays in compliance with all applicable quality systems and current cGMPs within the Quality Control department. They will operate as a core member of project teams to support improvements to QC systems and processes including assay performance, improving compliance, and efficiency. The primary goals of this team are to lead the execution of release and stability testing for commercial and clinical GMP, execute assay validation and assay transfer studies and critical reagent qualification studies; the implementation and maintenance of laboratory control procedures and compliance; raw materials and laboratory investigations.Job Duties:Lead method validation activities prior to the Gene Therapy Innovation Center's (GTIC) transfer to support the GTIC Validation Master Plan.Lead change controls for method revisions post validation to ensure continued performance of test methods in support of asset post-PPQ prior to GTIC method transferAuthor (review/approve) and execute method transfer protocols to ensure analytical QC readiness at GTIC in line with GTIC manufacturing and project timelinesSupport of CQV activities in GTIC by providing QC ownership on documents such as IQ/OQLead bridging activities for equipment changes in support of GTIC readiness prior to equipment purchase to support facility and laboratory start-upLead training strategy and serve as the SME for training of new employees and contractors in associated methods for GTIC readiness.Performs quantitative analytical assays as routine testing in support of release and stability studiesActs as a resource to junior QC analysts (and contractors), both from a technical and GMP-compliance standpoint. Participate in establishing and maintaining laboratory systems and controls. Active in maintaining the compliance of the laboratoryAuthor GMP documents such as analytical methods/forms, technical protocols/reports, CAPAs, and change controlsIndependently complete complex deviation reports and investigationsConduct wide variety of assays or tests required to characterize and qualify assay-specific reagents, such as qPCR primers and probes.Provide routine support and communication to groups external to QC. Interfaces with other departments within the organization and participates on project teams.  Act as a delegate for the QC Lead/Leader at meetings, including GTIC project.With guidance, act as the Subject Matter Expert during regulatory audits for their respective assays and will interact directly with regulatory auditors.
