Quality Assurance Coordinator

Provides coordination and Quality Management System (QMS) support to the Quality Assurance Department. Responsible to support maintenance, monitoring, review and publishing of Quality System Documents supporting the Quality Management Systems (QMS). Assists with audits, inspections and meetings as required.QA 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 expertise. Independently 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 documents. Support 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 review. Support QA audit team in managing auditor requests during the audit/inspection. Generate record/notes of audit discussions and findings.QA Meetings (10-15%) Plan and coordinate QA Department meetings including scheduling and agenda planning. Generate QA Department meetings minutes and circulate for review. Provide meeting support to QA team members as required.Additional 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 practices Proficiency with MS Office (Word, Excel, Power Point, Outlook and Teams) Strong written and verbal communication skills. Strong time management skills.$42,000 - $70,000 a yearWe 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.