What You'll Do:
- Assist Auditors with Sponsor audits and regulatory authority inspections to facilitate the auditing & inspection process
- 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 Audit
- Quality control of Standard Operating Procedures (SOPs) ensuring consistency in formatting, spelling, etc.
- Manage the distribution process for company SOPs
- Recommend changes to current processes to provide more effective use of the LMS and take the lead to implement such changes
- Create/format document templates & trackers
- Maintain quality records per SOPs
- Work closely with Auditors to learn and enhance Quality Assurance responsibilities
- Assist with maintaining audit schedules and tracking of deliverables
- Assist QA Auditors with conducting Vendor Audits, Internal System Audits and Computerized Systems validation, gaining experience to begin completing these tasks independently
- Assist in coordination of all activities related to the QMS, including but not limited to co-administration, routine review of quality control documentation, and development and execution of system user acceptance testing documentation
- Assist with the creation of procedures and work instructions/job aids relating to the QMS ensuring consistency and quality of content
- Assist QMS Document owners/users with entry of data into QMS
- Assists management with timely and appropriate follow up of deviations and CAPAs in the QMS in accordance with internal policies/SOPs
- Assist with completion of RFIs related to Quality Management Systems
- International region-specific functions
What You'll Bring:
- Bachelor’s Degree or equivalent combination of education and experience
- 0-1 years of work experience
- Basic understanding of GxP Guidelines, namely ICH/GCP Guidelines and relevant country specific regulations
- Excellent verbal and written communication skills
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 invest in your professional growth. Through a structured mentoring program, leadership development courses, and access to ongoing education and training opportunities, including tuition reimbursement, you’ll have the tools to achieve your goals. Our dedicated training department supports your successful career at CTI.
- Be Part of an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with generous health benefits, vacation packages, hybrid work opportunities, and paid parental leave. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
- Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.
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
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
