Quality Assurance Coordinator

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 Skills

• Diploma or bachelor's degree in a related field
• 1 - 3 years of relevant experience
• Quality 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.