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 Lake County, IL currently has an opportunity for a Sr. IT Compliance Analyst - CAPA
WHAT YOU'LL DO
Leads the IT Compliance activities for specific CAPA (Corrective and Preventive Action) event evaluations, investigations and resolution planning. Typically has responsibility for medium
to large events.
Assembles CAPA SME team with all needed parties/expertise to effectively and efficiently address assigned CAPA events.
Ensures CAPA events are investigated and remediated according to schedule.
Applies IT project delivery, application support and compliance knowledge and experience to CAPA investigations.
Prepares and approves documentation per policy and procedure to support CAPA activities.
Provides understanding and leadership of CAPA processes, SLC, validation and compliance processes/procedures.
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
Monitors implementation plan and effectiveness check due dates and works with BTS IT owners to ensure implementations are completed on time.
Escalates ER status, implementation and effectiveness issues to CAPA management as needed.
Works with Event owners to ensure CAPA Dashboard reflects the current status of all IT CAPAs.
Core Job Responsibilities:
Develops the CAPA strategy and approach for medium to large CAPA events.
Assembles and leads virtual team to develop, review and approve CAPA documentation (evaluation, investigation, containment, resolution, implementation, and effectiveness checks) in
support of IT quality activities
Understands the IT operating model and is adept at forming a team of SMEs to complete all aspects of the CAPA within the needed timelines. Holds team members accountable.
Escalates appropriately. Creates ownership and momentum across needed organizations, functions and partners.
Communicates CAPA progress by producing status reports to provide timely and accurate status to IT management.
Performs work using standard 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.
Establishes CAPA tasks and timelines and is held accountable to them.
Capture and report on IT Compliance data and metrics for assigned CAPAs and identifies potential process improvements
Adheres to established policies and procedures and assists in the establishment of regulated policies and procedures at the departmental level.
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.
Position Accountability / Scope:
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.
MINIMUM EDUCATION AND EXPERIENCE YOU'LL BRING
4-6 years of experience in a IT project delivery, IT application support, SLC methodologies, CAPA and quality systems environment.
Excellent analytical, judgment, consultative capabilities and communication skills. The ability to work with both IT management and staff.
Builds needed relationships and drives for results.
Excellent written communication skills.
Either is a ABBOTT CAPA certified event owner or will work to achieve this certification
Education: Bachelor's Degree or equivalent certification or experience. No advanced degree required
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
A fast-paced work environment where your safety is our priority (Manufacturing roles only)
Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)
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
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.
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.