Validation Specialist

3+ years

Not Disclosed

Abbott Park

15 June 7, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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 114,000 colleagues serve people in more than 160 countries.

VALIDATION SPECIALIST

ABOUT ABBOTT

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

WORKING AT ABBOTT

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

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.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 and @AbbottGlobal.

The base pay for this position is $64,000.00 – $128,000.00. In specific locations, the pay range may vary from the range posted.

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Validation Specialist

Job Description

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