QA Associate

What You'll Do

• Assist Auditors with hosting audits (Sponsor, Vendor, Internal, and Computerized Systems Validation) and regulatory authority inspections to facilitate the auditing and inspection process 
• Assist with tracking of audit deliverables  
• Work closely with Auditor level staff to learn and enhance Quality Assurance responsibilities  
• Assist with completion of Requests for Information (RFI) related to QMS 
• Manage (quality check, distribute, archive, track, etc.) the lifecycle of assigned Quality Management System Documents (e.g., SOPs, Manuals) utilizing SharePoint, the Learning Management System (LMS) and Document Management System (DMS)  
• Demonstrate consistent communication and coordination with QMS Document Authors and Review Teams 
• Assist with management of regional business continuity testing and updates to Business Continuity Plan 
• Recommend and implement QMS life cycle process improvements to provide more effective and efficient use of the systems and create respective document templates, work instructions, workflows, and job aids 
• Complete QA Help Desk Tickets related to QMS life cycle 
• MEA Region-Specific Functions:  Coordinate with departments to accomplish ISO 9001 standards requirements

What You'll Bring

• Bachelor’s Degree or equivalent combination of education and experience 
• At least 1+ years of work experience; candidates with fewer years of experience may be considered based on professional experience and/or education

About CTI 

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.

Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.

Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

We will never communicate with you via Microsoft Teams or text message

We will never ask for your bank account information at any point during the recruitment process