Sr Specialist, GDP Operational QA

Title: Sr Specialist, GDP Operational QALocation: Boston, MA (Hybrid)Employment Type: Contract (12+ Months)Status: Accepting CandidatesAbout the roleJoin a Quality Assurance team supporting distribution and logistics operations to ensure compliance with GDP and GMP requirements. This role focuses on providing day-to-day Quality oversight of third-party logistics providers and supporting distribution-related Quality Management System activities.The ideal candidate will have strong experience in GDP environments, distribution quality, and supply chain compliance.Key ResponsibilitiesProvide Quality oversight of third-party logistics (3PL) distribution partnersSupport preparation and maintenance of Quality AgreementsReview and support resolution of deviations, CAPA, and change controlsMaintain and track key performance indicators (KPIs) related to distribution activitiesSupport release of finished goods at third-party logistics locationsAnalyze compliance issues and escalate risks when necessaryMaintain Quality Management System (QMS) documentation related to distribution operationsSupport product recalls and mock recall activitiesParticipate in GDP Management Review activitiesSupport new product launch activities related to distribution requirementsAssist with regulatory inspections and audit readiness activitiesEnsure distribution licenses remain compliant and updatedParticipate in distribution expansion and Quality improvement projectsQualificationsMasters degree with 35 years of relevant Quality experience,ORBachelors degree in a scientific or allied health field with 5+ years of relevant experience5+ years of experience working in a Quality roleStrong experience working in GDP (Good Distribution Practice) environmentsExperience supporting distribution, logistics, or supply chain Quality operationsExperience supporting 3PL oversightExperience reviewing deviations, CAPA, and change controlsStrong knowledge of GDP and GMP regulationsExperience working with Quality Management Systems (QMS)Strong attention to detail and documentation review skillsStrong communication and stakeholder collaboration skillsPreferred QualificationsExperience supporting finished goods releaseExperience supporting distribution licenses and regulatory complianceExperience supporting new product launch distribution activitiesExperience supporting recall and mock recall programsExperience supporting regulatory inspectionsExperience working in pharmaceutical or biotechnology environmentsCompensationEstimated hourly range: $50$60/hr (W-2)Final rate within this range will be based on skills, experience, and interview results.Work Schedule: Hybrid Boston, MA