CQV Specialist ; Lab

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.

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.

• Manageandexecutevendorandinternalcalibration&preventivemaintenanceprograms,includingthereviewandapprovalofservicerecordsandreports(e.g.,calibrationcertificates,completedprotocols,work orders,andvendorreports) toensurecompletenessandaccuracy
• Performequipmentqualificationandvalidationactivitiesacross Atom Vie .SuchasexecutingHPLCannualqualifications,Gas Chromatographyequipmentqualificationandbalancesperformanceverificationandannualcalibrationetc.
• Create/DevelopthelabinstrumentoperationalSOPandmaintenanceprogramsinCMMS.
• Lead/Supportthedevelopmentandexecutionofallqualificationdocumentationrelatedtolaboratoryequipmentandsoftwarevalidation.
• CollaborateacrossteamsandlocationstoensurecalibrationprogramsareimplementedandmaintainedinaccordancewithcGMPsandthe Validation Plan .
• 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.

• 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.

• Aminimumofa College Diplomainatechnicalfield (Metrology,Pharmaceutical Sciencesetc.,)orrelevantexperience.
• Minimumof2-5yearshandsonworkingexperienceinGMPPharmaceuticallabsettingpreferablythe
  
  Metrologyrole.
• Ability to lift 50lbs, crawl, stoop, crouch, and kneel in small spaces.

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.