QC Scientist, Analytical Trainer

Role: QC Scientist specializing in Analytical Training, responsible for owning and enhancing the QC training program, developing training materials, and ensuring compliance with regulatory standards. Objectives include building infrastructure, monitoring KPIs, and driving continuous process improvements to ensure 'Right-First-Time' lab operations. Responsibilities encompass representing QC in cross-functional forums, authoring technical documents, mentoring staff in laboratory techniques (e.g., cell assays, flow cytometry, qPCR, ELISA, LIMS), and supporting regulatory inspections. Requirements: Bachelor’s in science with 6+ years of analytical QC experience in regulated environments; strong technical writing, adult learning, and training expertise; ability to interpret cGMP and regulatory requirements. Preferred skills include experience with laboratory techniques, process improvement, and cross-functional collaboration. High-value specifics: focus on analytical QC within biopharma, likely involving biologics or cell/gene modalities, with emphasis on adult learning, technical documentation, and regulatory compliance. The role operates independently, interfaces across departments, and supports audits. Location: U.S.-based, with flexible work setup and potential travel. The position demands proven expertise in laboratory techniques, training, and QMS compliance to support quality systems in biopharma manufacturing and testing.