Auditor II QA

JOB PURPOSE / SUMMARY

Responsible for assessment of quality and compliance according to CTI and/or Sponsor SOPs and all relevant regulations and guidelines

ESSENTIAL FUNCTIONS

• Host Sponsor audits of CTI 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
• Host Regulatory Authority inspections of CTI. Assist the organization in preparation for, coordination, hosting, conduct, documentation and follow-up of regulatory inspections
• Clearly communicate and report (verbally and in writing) audit outcomes and escalating significant compliance concerns to project teams, QA and CTI management and sponsor contacts appropriately
• Prepare training materials and conducting training related to relevant QA topics for CTI staff
• Report, manage and follow deviations, complaints, issues, non-conformances and their related CAPAs
• Prepare audit plans for audits and projects and programs, as needed
• Conduct Vendor Audits, Internal System Audits, Site Audits and Computerized Systems and Database Validation Audits. Identify and follow-up on any unresolved audit findings identified in a Quality Assurance Audit
• Conduct Sponsor-contracted audits, such as: Clinical Study Report Audits, Clinical Protocol Audits, Clinical Database Audits, Investigator Site Audits, etc. on an ad hoc or scheduled basis as determined by the Sponsor and CTI management
• Assist with creation, review, revision and management of SOPs
• Provide content and/or present quality related information at capabilities presentations
• Assist with completion of RFIs related to Quality Management Systems
• Assist in the review of Quality Assurance agreements related to projects or client master service agreements
• International region-specific functions

What You'll Bring:

• Education: Bachelor’s degree in Pharmacy or an equivalent combination of education and relevant experience.
• Experience: 3–5 years of relevant experience in clinical research and/or in a CRO environment, specifically within Quality Assurance.
• Certifications: Certification in auditing (RQAP, ASQ) or other quality-related certifications preferred.

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?

At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.

• 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 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 hybrid work from home opportunities. 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 @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