Quality Process Specialist II

Quality Process Specialist II - Office Hybrid - Sofia, Bulgaria or Warsaw, Poland

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

In summary, the Quality Process Specialist supports the users of ICON’s electronic document management system (EDMS), audit & CAPA management system (ACMS) and quality data archiving solution by trouble shooting issues, performing administrative activities, developing user training, and participating in system changes for optimizations.

Soft skills: Time Management, teamwork, communication, problem solving, willingness to learn, risk management.

The team is in 5 different countries, flexibility in working schedule is a must to accommodate meetings.

 What you will be doing:

- User acceptance testing (authoring scripts, administering scripts, tester training and script execution).
- Experience with customer support solutions for the review and resolution of user issues.
- User Support via phone and email.
- Experience with content management systems and quality Management systems (Vault Quality and TrackWise Digital preferred).
- Understanding of quality procedures, the CRO industry and Clinical Trials
- Experience in System Development Lifecycle, Change Management, Requirements gathering.
 

To be successful in this role you will need:

- Bachelor’s Degree or equivalent.
- 3 years of experience in Quality Management Systems.           
- Experience implementing systems and process solutions
- The ability to mentor and train other team members on system and process
- Strong knowledge of systems architecture and experience with application specific processes.
- Strong familiarity with systems specific processes related to data/document management etc.

- Excellent command of English.
- Strong communication skills (written and verbal)
- Strong problem solving and analytical skills to troubleshoot problems.

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What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply