Job description
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
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 () 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.
Originally posted on Himalayas
Who can apply
Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.