QC/Production Associate I

QC/Production Associate IJoin our team as a QC/Production Associate I, where you'll play a key role in producing life-changing drug products and ensuring their quality through hands-on work with advanced radio synthesizers and analytical equipment.Title: QC/Production Associate IDepartment: Network OperationsReports To: Facility ManagerCompensation Range: $30 - $32 hourlyOverviewThe QC/Production Associate I will operate the radiosynthesizers for the production of drug product, as well as operate analytical equipment for the quality control of drug product.Essential Duties and ResponsibilitiesPerform FDG and NaF synthesis according to Standard Operating Procedures (SOPs)Ensure all materials/reagents are accepted according to SOPs and within expiryEnsure all equipment is appropriately qualified prior to useOperate the synthesis unit according to SOPsLearn the basic operational principles of the synthesis unit and assist in routine maintenance of the synthesis unitPerform FDG and NaF quality control (QC) processes according to SOPsAssist with basic maintenance of QC equipmentEnsure all equipment is appropriately calibrated and qualified prior to useOperate the QC equipment according to SOPsEnsure completion of applicable cGMP documentationAssist with inventory managementMaintain production/QC/cleaning supply levels as appropriateAssist with inventory reportingPerform material acceptance according to SOPsCommunicate with local and Network support resources to troubleshoot equipment, production, or QC issuesPerform basic computer-controlled cyclotron operations for FDG and NaF production under the advisement of site Cyclotron and Facility EngineerMaintain a clean and safe working environmentPerform radiation safety duties according to SOFIE's Corporate Radiation Compliance Program and site licensing requirementsMaintain all qualification and validation requirements for entering ISO classified areaClean classified and non-classified areas according to SOPsPerform environmental monitoring of classified areas according to SOPsReport manufacturing metrics into data repository as requiredComplete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to:InvestigationsCorrective and Preventative ActionsDeviationsOut of SpecificationsNo or Atypical YieldsManufacturing and QC RecordsLogbooksAttend internal meetings as requiredOther assigned duties as requiredQualificationsHigh school diploma required; associates degree in chemistry, engineering, or natural sciences preferredTechnical experience with computer-controlled automation preferredEfficient in the use of MS Office Suite requiredAbility to work various shifts and weekends requiredAbility to be detail-oriented, accountable, patient, organized, and work in a team environment requiredAbility to communicate professionally with colleagues and customers, have excellent attention to detail, and be dependable and responsible in a fast-paced, highly technical environment requiredAbility to lift ~50 lbs. requiredUp to 5% travel required