Quality Engineer

Job Description Quality Engineer (Contract) – GMP / ISO EnvironmentLocation: Phillipsburg, NJ (100% Onsite)Schedule: Monday–Friday, 8:00 AM – 5:00 PM (flexible)Duration: Up to 18 months (contract)Compensation: $36.06–$43.27/hour (based on experience)Start Date: ASAPOverviewOur client, a leading organization in regulated manufacturing, is seeking a Quality Engineer to support site-level quality assurance programs and continuous improvement initiatives. This individual will play a critical role in ensuring compliance with cGMP, ISO standards, and regulatory requirements, while partnering cross-functionally to drive quality performance and operational excellence.Key ResponsibilitiesLead and support Quality Management System (QMS) initiatives to ensure compliance with GMP and ISO requirementsDrive customer complaint investigations, working directly with customers and suppliers to resolve issuesManage and participate in internal, customer, and regulatory audits, including gap assessments and corrective actionsOwn and maintain CAPA (Corrective and Preventive Action) processes within assigned scopeEnsure ongoing cGMP compliance and identify opportunities for process and system improvementsDeliver GMP/GDP training to site personnelMonitor and improve quality metrics, including complaint response times and CAPA effectivenessSupport Change Control (Management of Change) processesConduct statistical analysis and process trending (SPC) to support data-driven decisionsLead or support validation activities for new and existing products/processesCollaborate with supplier quality teams to resolve material and performance issuesPartner with operations, R&D, procurement, and commercial teams to address quality concernsSupport cross-functional investigations into product and process deviationsQualificationsBachelor's degree in Chemistry or related scientific field5+ years of experience in quality engineering or related roleExperience in pharmaceutical, biotechnology, or chemical manufacturing environmentsStrong knowledge of cGMP and ISO 9000 standardsMinimum 3+ years in a GMP-regulated manufacturing facilityKey Skills & CompetenciesStrong analytical and problem-solving abilitiesExcellent written and verbal communication skillsExperience with quality systems: CAPA, audits, validation, complaint handlingFamiliarity with chemical nomenclature and QC testing methodsAbility to work effectively in a matrixed, cross-functional environmentStrong project management and organizational skillsProven ability to influence and lead without direct authorityWork EnvironmentManufacturing setting requiring appropriate PPE in designated areasOccasional domestic travel may be requiredInterview ProcessInitial 15-minute virtual interviewFinal onsite interview (approximately 2 hours) with cross-functional team