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Senior Clinical Quality Coordinator
- Abbott (Maple Grove, MN)
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
+ A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.
The Opportunity
Our location in Maple Grove, MN currently has an on-site opportunity for a **Senior Clinical Quality Coordinator** . This new team member will work independently, provide clinical quality team support to ensure compliance with applicable regulatory standards and Abbott Standard Operating Procedures. Additionally, independently manage document control change orders and provide clinical training (LMS) support and system training.
What** **You’ll** **Work On
+ **Windchill Global Clinical Lead Librarian** - Provide onsite and remote support to Global Clinical Affairs Organization (GCAO) within the Global Clinical Library. Includes requesting the appropriate access and providing librarian support. Initiate and manage IT intake requests for clinical systems improvement needs. Execute judgement when the requests require full management approval, and when admin changes can be granted. Advanced knowledge in the document control and procedures management, leads the organization in execution of document control policies.
+ **Windchill Change Orders** – Independently manage document control change orders in Windchill. Serve as SME for the clinical document control process: track document control changes requests, oversee periodic document review schedule, support with impact assessment of document control changes within Clinical quality system, distribute release memos for the clinical documents, as aligned with clinical quality management. Monitor the need for documents updates, forms updates based on teams feedback and evolution of the business needs.
+ **Clinical Training Support** - Provide onsite and remote support to GCAO within LMS for both procedure and study training questions. Includes requesting the appropriate access and running LMS reports as needed. Maintain tracker of employees on leave, understand GCAO vs non-GCAO training assignments. Monitor and lead training audiences’ updates, communicate with management on the needs to review audiences and, following to the changes in procedures, assess appropriateness of assigned training, recommend changes and execute on approval.
+ **Clinical Quality support for Documentation management for studies** – assist with possible solutions and compliance questions to good documentation practices questions. Train GCAO employees on self-use of Windchill Clinical Library.
+ Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Required Qualifications
+ Associate’s degree or an equivalent combination of education and work experience
Preferred Qualifications
+ 2 - 4 years clinical research experience or quality system experience in device/pharmaceutical companies or relevant clinical experience in a clinical/hospital environment.
+ Proficient in operating a personal computer and in using various PC-based software packages including Microsoft Word, Excel, PowerPoint, Windchill or similar word processing/spreadsheet software.
+ Ability to use discretion and handle sensitive/confidential information.
+ Ability to work in a highly matrixed and geographically diverse business environment
+ Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects
+ Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
+ Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to maintain regular and predictable attendance.
+ Ability to travel between company facilities, visit labs, and other areas as necessary
**Learn more about our benefits that add real value to your life to help you live fully: ** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is $21.05 – $42.15 per hour. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email [email protected]
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