Manufacturing Assurance Specialist

Seeking a detail-oriented Investigation Specialist to support manufacturing operations by leading deviation investigations, identifying root causes, and ensuring effective corrective and preventive actions (CAPA) in a regulated (cGMP) environment.Key Responsibilities:Investigate manufacturing deviations, environmental monitoring excursions, and calibration issuesPerform root cause analysis and assess impact on product and productionCollaborate with Manufacturing, Quality, Facilities, QC, and QA teams to resolve issuesGenerate clear, compliant investigation reports with corrective/preventive actionsSupport CAPA, change control, and documentation management (DCM) activitiesReview manufacturing, facility, and environmental monitoring records to support investigationsConduct facility and utility inspections and report potential risksEnsure compliance with regulatory and industry standardsRequirements:Hands-on experience in manufacturing, validation, or aseptic processingStrong technical writing, analytical, and problem-solving skillsExperience with CAPA, deviation investigations, and root cause analysisFamiliarity with cGMP, FDA regulations, and quality systemsProficiency in MS Office and systems such as SAP, LIMS, or DCMAbility to work independently in a fast-paced, regulated environment