CQV Specialist ; Lab
Job in
Hamilton, Ontario, E8H, Canada
Listed on 2026-10-11
Listing for:
AtomVie Global Radiopharma Inc.
Full Time
position Listed on 2026-10-11
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, QA Specialist - Analyst/Manager -
Engineering
Regulatory Compliance Specialist, Quality Engineering, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Atom Vie 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 Atom Vie today and help us achieve our vision: to transform lives by revolutionizing healthcare.
About
The Role
Reporting to the Engineering Manager as a CQV Specialist (Lab) ,assistthe
Engineeringdepartmentfocusedonlaboratoryequipmentqualifications,calibrations,recertifications,anddocumentationexecutionincompliancewithGMPpractices.
Thisrolewillalsocoordinatethird-partycontractorsandcontributetothecontinuousimprovementoftheengineeringdepartment..
This posting is for an existing vacancy to support the expansion of the company.
What You Will Do
Manageandexecutevendorandinternalcalibration&preventivemaintenanceprograms,includingthereviewandapprovalofservicerecordsandreports(e.g.,calibration certificates,completed protocols,work orders,andvendorreports) toensurecompletenessandaccuracy
Performequipmentqualificationandvalidationactivitiesacross Atom Vie .SuchasexecutingHPLCannualqualifications,Gas Chromatographyequipmentqualificationandbalancesperformanceverificationandannualcalibrationetc.
Create/DevelopthelabinstrumentoperationalSOPandmaintenanceprogramsinCMMS.
Lead/Supportthedevelopmentandexecutionofallqualificationdocumentationrelatedtolaboratoryequipmentandsoftwarevalidation.
CollaborateacrossteamsandlocationstoensurecalibrationprogramsareimplementedandmaintainedinaccordancewithcGMPsandthe Validation Plan .
InvestigateandtroubleshootproblemsrelatingtoanyCQVtasks.
Providetechnicalassistanceduringinvestigationsofequipmentandvalidationissues,aidintheresolutionofqualification/validationdeviationsandprotocoldiscrepancies.
Lead/Support non-conformancesrelatedtodeviationsoccurringwhenequipmentfailstomeetacceptancecriteria
AssistorleadthetroubleshootingandrepairofproductionandQCrelatedequipmentasneeded
Co-ordinatewiththedirectsupervisorandtechnicianstoensuremanagementandQAareinformedofcompliancestatusandadherencetocommitments.
Lead and author nonconformance reports, change controls, and CAPAs, ensuring follow-through to completion within the proposed timeline.
What You Bringtothe Role
Soundknowledgeofauthorityregulationslike Health Canadaand FDAetc.
Excellentknowledgeofoperating
EmpowerCDSandoperatingandtroubleshootingon
WatersHPLCsystems.
Demonstratedabilitytosuccessfullyprioritize,managetimewell,multitask,and troubleshoot.
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
Aminimumofa College Diplomainatechnicalfield (Metrology,Pharmaceutical Sciences etc.,)orrelevantexperience.
Minimumof2-5yearshandsonworkingexperienceinGMPPharmaceuticallabsettingpreferablythe
Metrologyrole.
Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.
Compensation
Annualsalarystartsat $64k.Compensationisbasedonrelevantindustryexperience,academic credentials,and qualifications.
Group Health&Dental Benefits(fromday1)
RRSPMatching Program
Employee Assistance and Wellness Programs
Atom Vie 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 Atom Vie. 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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