What You'll Do
* Assist with or lead Sponsor audits and assure that issues from Sponsor audits are promptly communicated to the appropriate team members, assist with the development of a corrective action plan and facilitate resolution of all audit findings
* Assist Quality Assurance Directors hosting regulatory authority inspections
* Manage and initiate regional testing for the annual update of the Business Continuity Plan
* Assist in tracking audit findings, deviations and CAPAs identified in a Quality Assurance Audits
* Quality control of Standard Operating Procedures (SOP) ensuring consistency in formatting, spelling, etc.
* Manage the distribution process for company SOPs and assign SOP courses to appropriate roles in LMS
* Assume administrator responsibilities for quality assurance electronic systems. Create new accounts and assign appropriate roles/access.
* Recommend changes to current processes to provide more effective use of the quality assurance electronic systems and take the lead to implement such changes
* Prepare training materials and conducting training related to relevant QA topics for CTI staff
* Create and format document templates & trackers
* Work closely with Auditors to learn and enhance Quality Assurance responsibilities
* Conduct Vendor Audit Questionnaires, Internal System Audits, Internal Trial Master File Audits and Computerized Systems validation. Identify and follow-up on any unresolved audit findings identified in a Quality Assurance Audit
* Assist with completion of RFIs related to Quality Management Systems
What You'll Bring
* 2 years of related experience or relevant pharmaceutical and/or CRO experience in Quality Assurance
* Bachelor's Degree or equivalent combination of education and experience
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
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 email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ) 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