Senior Quality Auditor

**Auditor**
**(Level depending on Experience)**
**Job Purpose/Summary**
Responsible for assessment of quality and compliance according to CTI SOPs and all relevant regulations and guidelines.
**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 Bring**
- Basic understanding of GxP Guidelines, namely ICH/GCP Guidelines and relevant country specific regulations
- Excellent verbal and written communication skills
- Computer literacy in MS Word, Excel and PowerPoint
- Excellent prioritization and organizational skills
- Excellent analytical and skills
- Ability to work effectively and successfully in a team environment
- Ability to think critically and creatively
**Why CTI?**
At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.
For that reason, we treat our team members with the respect they deserve, and our numbers show it:
- We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
- We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
- Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
- We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
- We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
- Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
After an appropriate period of training, we offer you an unlimited, varied and attractive job in an international company.

---