QA/QC Lead

Elektrofi, Inc. is seeking a QA/QC Lead to join our Quality panyElektrofi is a growing biologics formulation company focusing on the subcutaneous delivery of proteins. We deliver ultra-high concentration doses of proteins using our proprietary microparticle technology. This technology aims to expand access to biologics by replacing time-consuming, clinician-administered intravenous infusions with rapid subcutaneous injections that can be performed at home. We are headquartered in the Boston Seaport. [summaryElektrofi is seeking a QA/QC Lead to join our team. This professional will be responsible for the planning, coordination, build up, execution, and maintenance of our quality systems. You will play a key role in leading and supporting the organization with development of processes in QA and QC. This individual will join an early-stage, multidisciplinary team of scientists and contribute to a variety of platform development activities in a highly collaborative environment.ResponsibilitiesResponsible for the development of QMS procedures for QA and QC processesGuide development of analytical and production procedures, methods and review of instrument & equipment qualification and tech transfer documents & recordsProvide quality oversight of internal Analytical Development, Formulation Development, Process Development and Translational Development groupsDrive the development of cross-functional process guides, process maps, training plans and training contentProvide ongoing external third-party oversight including vendor selection, qualification, audits, quality agreements, metrics, risk assessments, SOPs, validations, batch record reviews, product releases, and investigationsEnsure timely close-out of deviations, investigations, change controls, complaints, and any other documentation associated with contracted vendors and suppliers.Ensure customer and regulatory requirements are determined and met Key Qualifications10+ years'' experience working in quality assurance and quality controlA scientific or management degree with pharmaceutical and biotechnology certificationsStrong team player who can rapidly build positive relationships and proactively partner across teamsExcellent communication and listening skills across all levelsExceptional organizational and analytical skillsSuperb attention to detail and a passion for quality results

Created: 2026-03-07