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.

JOB DESCRIPTION:

CAPA Specialist Gurnee, IL

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbotts life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health. Our pioneering technology spans the world of healthcare operations with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

WHAT YOULL DO

We are recruiting for a CAPA Specialist to join our team within our Infectious Disease Developed Markets (IDDM) business unit located in Gurnee, IL. In this role, you will be responsible for ensuring the CAPA system is being managed effectively as part of the CAPA Administration group. You will work cross-functionally with others in the organization to ensure Quality System processes are compliant to internal and external requirements.

* Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items.
* Support and guide the Corrective Action Review Board and Users regarding the CAPA process, CAPA record content, and CAPA software.
* Support the development, implementation and continuous improvement of Quality System CAPA procedures, CAPA software, and CAPA training.
* Ensure implementation, and effectiveness verification of CAPA and participate in remediation of legacy CAPA files.
* Ensure that CAPA records are complete and they contain accurate links and references to other Quality processes such as Change Management, Non-Conformance, and Complaint Handling.
* Manage the archival and handling of scanned CAPA records.
* Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.
* Demonstrates commitment to the development, implementation and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.
* Provide ongoing support to Quality management during external audits.
* Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
* Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companys policies and practices; build productive internal/external working relationships
* Carries out duties in compliance with established business policies
* Other duties as assigned, according to the changing needs of the business

EDUCATION AND EXPERIENCE YOULL BRING

Required

* Bachelor's Degree in Biology, Chemistry, Life Sciences, or another related technical field
* 4+ years of experience in a FDA controlled environment initiating, reviewing, and/or tracking of CAPAs
* Demonstrated ability to find root cause of why an issue occurred, review action plans, and determine if the actions taken effectively address the issue
* Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
* Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization
* Proficient in MS Office (Word, Excel, PowerPoint, Outlook)

Preferred

* Advanced level degree in Biology, Chemistry, Life Sciences, or another related technical field
* Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic
* Knowledge of the QSR and/or ISO 13485

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 FAMILY:

Operations Quality

DIVISION:

ARDx Abbott Rapid Diagnostics

LOCATION:

United States > Gurnee : J54

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf