Sr. IT Compliance Analyst - CAPA

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 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Our location in Lake County, IL currently has an opportunity for Sr IT Compliance Analyst – CAPA. Establishes and maintains productive relationships with all levels in the BTS and Divisional IT organizations and business functions. Acts as a liaison and IT Compliance expert to assure successful investigations and corrective actions. Serves as a source of information on the IT Compliance needs and regulatory environment.

What You’ll Work On

• Leads the IT Compliance activities for specific CAPA (Corrective and Preventive Action) event evaluations, investigations, and resolution planning.
• Assembles CAPA CFT (cross-functional team) team with all needed parties/expertise to effectively and efficiently address assigned CAPA events.
• Provides understanding and leadership of CAPA processes, SLC, validation and compliance processes/procedures to CAPA CFT (and other stakeholders as needed). 
• Exercises Project management skills to drive for completion of CAPA events (assignment of action ownership, details, milestone dates)
• Ensures CAPA events are investigated and remediated according to schedule.
• Applies IT project delivery, application support and compliance knowledge and experience to investigations. 
• Monitors implementation plan and effectiveness check due dates and work with BTS IT owners to ensure implementations are completed on time.
• Escalates status, implementation, and effectiveness issues to CAPA management as needed.
• Prepares and approves documentation per policy and procedure to support CAPA activities.
• Accountable for capturing, reporting, and evolving the CAPA metric data for BTS. Prepares management review metrics for upper management communications and provides input as needed for GMR metrics
• Apply AI technologies and agent-based solutions to improve quality processes, support investigations and compliance activities, and expand AI expertise through ongoing learning and best practice adoption.
• Core Job Responsibilities
• Develops the CAPA strategy and approach for CAPA events.
• Assembles and leads CFT (virtual or onsite)  to develop, review and approve CAPA documentation (evaluation, investigation, containment, resolution, implementation, and effectiveness checks) in support of IT quality activities.
• Applies critical thinking and reasoning skills to incorporate CFT input into a well-organized and complete CAPA event record.
• Implements technical writing and clear and concise conclusions in the documentation of CAPA events.
• Performs work using BTS Quality System methodologies, processes, and tools to ensure IT Compliance.
• Resolve issues that may delay the CAPAs or otherwise subject the company to financial or regulatory risk.
• Support the development and oversight of AI agents and AI-enabled processes, ensuring responsible AI usage, compliance with company policies, and continuous advancement of AI knowledge and capabilities across the organization.
• Works with minimal management direction. Drives completion of CAPAs by organizing and monitoring the efforts of CAPA SME teams.
• Independently conceives and develops approaches to the solution of CAPA events which require application of IT compliance principles.
• Errors or failure to achieve expected results may result in quality issues and/or the expenditure of more resources or impact IT compliance.

Education & Required Qualifications:

• Bachelor’s Degree or equivalent certification or experience. No advanced degree required

Required Experience:

• Overall 5+ years of experience in IT project delivery, IT application support, SLC methodologies with about 2-4 years in CAPA and regulated quality systems environment.
• The individual should either be a CAPA Certified Event Owner or be willing to obtain certification.
• Strong analytical thinking, sound judgment, consultative skills, and the ability to effectively partner with both IT management and technical teams.
• Proven ability to build strong stakeholder relationships, drive results, and communicate effectively through both verbal and written channels.

Preferred Experience:

• Familiarity with AI technologies and agent-based solutions to improve quality processes.
• AQR certifications.
• Life sciences industry background

Misc: This is an onsite role at Abbott location in IL This is not a remote role/opportunity.

• Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com
• Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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.

     

The base pay for this position is

$78,000.00 – $156,000.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Information Risk & Quality Assurance

     

DIVISION:

BTS Business Technology Services

        

LOCATION:

United States > Waukegan : J46

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

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