Quality Assurance Coordinator

August 21

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Alimentiv

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Healthcare Insurance • Science • Pharmaceuticals

Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.

201 - 500 employees

Founded 2020

⚕️ Healthcare Insurance

🔬 Science

💊 Pharmaceuticals

📋 Description

• 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. • Provide input to QA department processes to support continuous improvement activities. • 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. • 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. • 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.

🎯 Requirements

• 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.