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Sr. IT Compliance Analyst - CAPA
Waukegan, IL
Job Description
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 109,000 colleagues serve people in more than 160 countries.
Our location in Waukegan, currently has an opportunity for an IT CAPA Quality consultant
WHAT YOU'LL DO
* Ensures CAPA system is fully implemented and integrated with other
* elements of quality management system. Promotes recognition of quality
* program among IT and business colleagues and collaborators.
* Coordinates, reviews, tracks, and reports on the nonconformance, CAPAs,
* and deviations that are generated as part of the CAPA quality system.
* Prepares and approves documentation per policy and procedure to
* support the CAPA quality system.
* Responsible for designing and maintaining programs for the systematic
* monitoring and evaluation of the various aspects of a project, or service
* to ensure that standards of quality are being met.
Core Job Responsibilities
* Evaluates and provides guidance on the methods and procedures to input quality
* events into the CAPA system. Assists with analysis of quality data to identify
* problems or unfavorable trends that may require corrective or preventive actions.
* Provides independent review of investigations associated with nonconformances and CAPA, deviations, and change control activities. Challenges the quality data information system.
* Ensures that the data received by the CAPA system are complete, accurate and timely.
* Oversees and monitors the open nonconformance's to ensure all activities are being completed in a timely manner. Identifies recurring events and ensures appropriate actions are taken as necessary and any trends are escalated for review.
* Leads/facilitates continuous improvement initiatives based on feedback, process monitoring results, etc.
* Provides guidance on the CAPA system, event descriptions, investigations, root cause analysis, and resolution plans.
* Updates and reviews standard operating procedures, work instructions, forms and templates in support the CAPA Program.
* Assists as needed in audits and inspections. Supports GxP inspections and audits from both internal and external regulatory authorities and collaborators and
* supports drafting of follow-up responses for all aspects of the business.
* Assists on special projects and performs other activities associated with tracking of CAPAs, deviations and other exception records.
Position Accountability & Scope
* Individual contributor with comprehensive knowledge in the specific area.
* Ability to execute highly complex or specialized projects.
* Ability to adapt precedent and make significant departures from
* traditional approaches to develop solutions.
* Excellent analytical, judgment and consultative capabilities and communication skills and the ability to work with both IT management and staff
EDUCATION AND EXPERIENCE YOU'LL BRING
Required
Minimum Education
Bachelor's Degree or equivalent certification or experience
Minimum Experience/Training
4-6 years' experience in a quality systems
Supervisory / Management Responsibilities
No direct or indirect supervisory responsibility
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
* Training and career development, with onboarding programs for new employees and tuition assistance
* Financial security through competitive compensation, incentives and retirement plans
* Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
* Paid time off
* 401(k) retirement savings with a generous company match
* The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
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.
Job Summary
Company
Abbott Laboratories
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
4 to 6 years
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