Sr. IT Compliance Analyst - CAPA

Abbott Laboratories • Waukegan, IL

1d • $78,000 - $156,000 • Onsite

About The Position

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.

Requirements

• Bachelor’s Degree or equivalent certification or 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.

Nice To Haves

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

Responsibilities

• 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.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior