Validation Specialist
2 months ago
The Opportunity
This position works out of our Abbott Park, IL (Lake Bluff) location in the Core Lab Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
As the Validation Specialist , you’ll conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes, which adds value to the business.
What You’ll Work On
Contributes to defining and timely achievement of overall project goals. Scope typically limited to one specific QA function.
Provides compliant solutions to a variety of problems of moderate scope and complexity.
Interacts constructively with employees, managers, and cross-functional peers.
May lead a project with a limited scope, but usually a contributor on broader projects.
Provides guidance to other Professionals and Technicians.
Quality System Compliance -Maintains awareness of standards that regulate our industry.
Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.
Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
Risk Management - Applies basic Risk Management principles to work.
Participates in the development or modification of Risk management files.
Complaint Evaluation - Investigates complex complaints with management oversight.
Ensures compliant documentation related to area of responsibility.
Design Control / Documentation & Change Control - Identifies areas for process improvement.
Provides supporting information for change including reasons and justifications.
Quality Engineering - Coordinates quality decisions between different quality and engineering groups.
Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g., FMEAs).
Team member helping and interfacing with suppliers to deliver product meeting our quality requirements.
Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions. Provides compliant solutions to a variety of complex problems.
Ensures compliant documentation, conducting tasks related to area of responsibility with management oversight.
Decisions may have short- and long-term impact.
Required Qualifications
Apprenticeship or bachelor’s degree in Life Science, Engineering, or closely related discipline, or an equivalent combination of education and work experience.
Minimum 3 years experience working in Quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred Qualifications
Demonstrates understanding of how their function supports the business. Demonstrates technical and business competencies that drive results and continuous improvement.
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