Quality Assurance Coordinator

2 hours ago

Kitchener, Canada Alimentiv Full time

Get AI-powered advice on this job and more exclusive features.This range is provided by Alimentiv. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay rangeCA$42,000.00/yr - CA$70,000.00/yrQA Coordination and Document Management (55-65%)Independently review and triage high volume of incoming requests to QA and assign to QA staff based on area of expertiseIndependently review high volume of document change requests in the electronic quality management system (eQMS) and assign to QA staff based on area of expertise.Perform quality system document reviews using the eQMS and document quality checks as assigned to ensure documents meet the requirements of the QMS.Liaise with quality system document owners as required to seek clarity on processes outlined in quality system documentsSupport QA personnel with publishing quality system documents.Provide input to QA department processes to support continuous improvement activities.QA Audits/Inspection Management (15-20%)Assist with external audits and regulatory inspections, which may include preparation for audit/inspection (e.g., schedule audit participants, distribute audit agenda, book and prepare the audit meetings)Create audit folder and upload requested documents to shared folder for auditor reviewSupport QA audit team in managing auditor requests during the audit/inspection.Generate record/notes of audit discussions and findingsQA Meetings (10-15%)Plan and coordinate QA Department meetings including scheduling and agenda planningGenerate QA Department meetings minutes and circulate for reviewProvide meeting support to QA team members as requiredAdditional Knowledge and SkillsDiploma or bachelor's degree in a related field1 - 3 years of relevant experienceQuality Assurance or Clinical Research specialty preferred.General knowledge of regulations and standards governing global clinical research practicesProficiency with MS Office (Word, Excel, Power Point, Outlook and Teams)Strong written and verbal communication skills. Strong time management skillsWe may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.Seniority levelNot ApplicableEmployment typeFull-timeJob functionQuality AssuranceIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Alimentiv by 2xGet notified about new Quality Assurance Coordinator jobs in Kitchener, Ontario, Canada.We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

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