Senior Quality Control Specialist (Lead)

*This is an on-site position based in Wilmington, MA. Only candidates within a reasonable commuting distance will be considered. *Senior Quality Control Specialist???? Advance Quality at the Forefront of Nuclear MedicineEckert & Ziegler Radiopharma, Inc. (EZRI) is expanding its U.S. radiopharmaceutical manufacturing and CMO operations in Wilmington, MA — including the build-out and qualification of new Lu-177 production capabilities supporting targeted cancer therapies.We are seeking a highly capable, hands-on Senior QC Specialist to support analytical testing, microbiology, method transfer, and laboratory qualification activities within a regulated cGMP environment.This is not a routine bench role. It is an opportunity to strengthen and build QC systems during a critical growth phase in one of the most dynamic sectors of modern medicine.The OpportunityThe Senior QC Specialist reports into site Quality leadership and works closely with QA, Manufacturing, the Radiation Safety Officer, and Site Operations.This is a hands-on laboratory role with real ownership. A strong physical presence in the QC lab and engagement with manufacturing operations is expected. The position plays a key role in ensuring laboratory readiness, sterility assurance, data integrity, and timely product release.A major near-term priority is supporting Lu-177 expansion activities from a laboratory standpoint, including:Method transfer and qualificationEquipment IQ/OQ/PQ supportEnvironmental monitoring program strengtheningLaboratory inspection readinessThis role is ideal for a technical professional who thrives in growth environments and wants to help build and elevate QC operations — not simply execute static testing.Key ResponsibilitiesAnalytical Quality ControlPerform release and in-process analytical testing of radiopharmaceutical products (HPLC required; GC, ICP, or related systems preferred)Execute compendial and in-house methods in accordance with GMP standardsReview, trend, and evaluate analytical data in alignment with ALCOA principlesSupport OOS, OOT, deviation investigations, and CAPA activitiesContribute to batch record review and product disposition supportMethod Transfer & ValidationLead or support analytical method transfers into the QC laboratoryAssist with method qualification, validation, and verification protocolsAuthor and revise SOPs, test methods, and validation documentationEnsure laboratory methods meet regulatory expectations and inspection readiness standardsEquipment Qualification & Laboratory SystemsSupport IQ/OQ/PQ activities for QC instrumentation and laboratory equipmentCoordinate calibration and preventive maintenance programsMaintain laboratory systems in an audit-ready statePartner cross-functionally during equipment installation and commissioningMicrobiology & Sterility AssuranceExecute environmental monitoring of cleanrooms, isolators, biosafety cabinets, and hot cellsPerform viable and non-viable airborne particle monitoringConduct bioburden, endotoxin, and sterility testingTrend environmental data and support contamination control strategySupport aseptic process oversight from a QC perspectiveQuality & ComplianceMaintain GMP-compliant documentation and data integrity standardsSupport regulatory inspections and customer auditsIdentify and implement continuous improvement opportunities within QC operationsContribute to strengthening laboratory infrastructure as site operations expand???? Play a direct role in releasing life-improving radiopharmaceutical products.QualificationsBachelor’s degree in Chemistry, Biochemistry, Microbiology, Pharmaceutical Sciences, Nuclear Chemistry, or related scientific discipline (advanced degree preferred)5–8 years of QC experience in pharmaceutical or biotech manufacturingStrong hands-on analytical instrumentation experience (HPLC required)Experience performing microbiological testing (EM, sterility, endotoxin) in sterile environmentsExperience supporting method transfer and validation activitiesFamiliarity with equipment qualification (IQ/OQ/PQ) in a cGMP settingExperience in cleanroom and aseptic manufacturing environmentsWorking knowledge of FDA cGMP regulations (21 CFR Parts 210/211)Radiopharmaceutical experience preferredAbility to work safely with low-level radioactive materials (training provided)Work StructureOn-site in Wilmington, MAHands-on laboratory role within a cleanroom-based manufacturing environmentFloor-engaged, collaborative cultureActive participation in daily site execution Why Join EZRI? ????Contribute directly to the expansion of Lu-177 manufacturing supporting targeted cancer therapyWork in a growth-oriented, execution-focused GMP environmentBe part of a lean U.S. site backed by a global leader in isotope technologyCompetitive compensation, annual bonus eligibility, and comprehensive benefitsIf you are a technically strong, hands-on QC professional who values disciplined execution, inspection readiness, and meaningful impact in healthcare, we welcome the opportunity to connect.

Salary : $90,000 - $120,000