AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to transform patients’ lives by advancing high quality drugs for the treatment and diagnosis of diseases.
We are a community that challenges ourselves professionally, takes pride in what we can accomplish together and values the impact we can make with our partners and patients across the globe. Start your career with AtomVie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
AboutTheRole
Reporting to the Engineering Manager as a CQV Specialist (Lab),assisttheEngineeringdepartmentfocusedonlaboratoryequipmentqualifications,calibrations,recertifications,anddocumentationexecutionincompliancewithGMPpractices.Thisrolewillalsocoordinatethird-partycontractorsandcontributetothecontinuousimprovementoftheengineeringdepartment..
This posting is for an existing vacancy to support the expansion of the company.
WhatYouWillDo
- Manageandexecutevendorandinternalcalibration&preventivemaintenanceprograms,includingthereviewandapprovalofservicerecordsandreports(e.g.,calibrationcertificates,completedprotocols,workorders,andvendorreports)toensurecompletenessandaccuracy
- PerformequipmentqualificationandvalidationactivitiesacrossAtomVie.SuchasexecutingHPLCannualqualifications,GasChromatographyequipmentqualificationandbalancesperformanceverificationandannualcalibrationetc.
- Create/DevelopthelabinstrumentoperationalSOPandmaintenanceprogramsinCMMS.
- Lead/Supportthedevelopmentandexecutionofallqualificationdocumentationrelatedtolaboratoryequipmentandsoftwarevalidation.
- CollaborateacrossteamsandlocationstoensurecalibrationprogramsareimplementedandmaintainedinaccordancewithcGMPsandtheValidationPlan.
- InvestigateandtroubleshootproblemsrelatingtoanyCQVtasks.Providetechnicalassistanceduringinvestigationsofequipmentandvalidationissues,aidintheresolutionofqualification/validationdeviationsandprotocoldiscrepancies.
- Lead/Supportnon-conformancesrelatedtodeviationsoccurringwhenequipmentfailstomeetacceptancecriteria
- AssistorleadthetroubleshootingandrepairofproductionandQCrelatedequipmentasneeded
- Co-ordinatewiththedirectsupervisorandtechnicianstoensuremanagementandQAareinformedofcompliancestatusandadherencetocommitments.
- Lead and author nonconformance reports, change controls, and CAPAs, ensuring follow-through to completion within the proposed timeline.
WhatYouBringtotheRole
- SoundknowledgeofauthorityregulationslikeHealthCanadaandFDAetc.
- ExcellentknowledgeofoperatingEmpowerCDSandoperatingandtroubleshootingonWatersHPLCsystems.
- Demonstratedabilitytosuccessfullyprioritize,managetimewell,multitask,andtroubleshoot.
- Excellent verbal and written communication skills, with expertise in technical report writing and a strong ability to understand and analyze complex systems and trends.
Requirements
- AminimumofaCollegeDiplomainatechnicalfield(Metrology,PharmaceuticalSciencesetc.,)orrelevantexperience.
- Minimumof2-5yearshandsonworkingexperienceinGMPPharmaceuticallabsettingpreferablytheMetrologyrole.
- Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.
Compensation
Annualsalarystartsat$64k.Compensationisbasedonrelevantindustryexperience,academiccredentials,andqualifications.
- GroupHealth&DentalBenefits(fromday1)
- RRSPMatchingProgram
- EmployeeAssistanceandWellnessPrograms
AtomVie does not use artificial intelligence or automated decision-making tools in any part of the recruitment, screening, or selection process.
We are committed to fostering a workplace that values diversity, equity, and inclusion. We believe that a diverse and inclusive workforce enhances our ability to innovate, collaborate, and better serve our clients and patients. We thank you for considering a career with AtomVie. Only those candidates selected for an interview will be contacted. Accommodations are available upon request for candidates taking part in all aspects of the recruitment and selection process. We are dedicated to ensuring that every qualified applicant has an equal opportunity to thrive within our organization.
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CQV Specialist I (Lab) in Hamilton employer: AtomVie Global Radiopharma Inc.
At AtomVie Global Radiopharma, we pride ourselves on being an exceptional employer that fosters a culture of innovation and collaboration. As the Director of Quality Assurance, you will not only lead critical quality initiatives but also benefit from our commitment to employee growth through continuous training and development opportunities. Located in a dynamic environment, our team is dedicated to making a meaningful impact on patient lives while enjoying a supportive workplace that values excellence and integrity.
Contact Details:
AtomVie Global Radiopharma Inc. Recruitment Team
