Senior Quality Professional Validation

Abbott • Des Plaines, IL

16h • $78,000 - $156,000

About The Position

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: Senior Quality Professional Validation 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 At Molecular Diagnostics, we realize the potential of personalized care as the laboratory’s most trusted and preferred source for molecular diagnostic solutions. We are a division of Abbott Laboratories, a global, diversified healthcare innovator with a legacy of pioneering work in medical diagnostics. Position: Senior Quality Professional – Validation Location: Molecular Diagnostics Business Unit, Des Plaines, Illinois The Senior Quality Professional – Validation is responsible for ensuring compliance with applicable Corporate and Divisional policies and procedures. This role manages all validation activities, including protocol development, document review, controlled document storage, and resolution of problem reports. Key responsibilities include: Supporting CAPA activities within the Global Engineering Services (GES) organization Contributing to GES compliance and validation programs by maintaining records, preparing metrics, and tracking action items Assisting with internal, Corporate, Divisional, Regulatory, and third-party audits related to GES What You’ll Work On Write, review, approve and/or execute documentation for new and current validation procedures and technical reports related to qualified facilities/utilities/equipment, validated spreadsheets, validated systems, and/or validated processes. Represent division, department, and group interests as a QA Validation Representative in meetings, conference calls, or as needed. Ensure compliance with division, corporate, and regulatory requirements by providing quality guidance to customers and clients on policies and procedures related to development and validation. Provide support to ensure that Departmental Validation Master Plans are developed, approved in a timely manner, and adhered to. Investigate/troubleshoot validation problems for qualified facilities/utilities/equipment, validated spreadsheets, validated systems, and/or validated processes. Abbott Engineering Standards (AES) committee member Develop and evaluate quality process and system standards to ensure compliance with company standards and regulatory requirements. May assist with establishing and updating corporate validation policies. Conduct External Supplier Evaluations and manage the Approved Supplier List.

Requirements

• Bachelor’s degree in a related field.
• Minimum of 3 years of industry experience, preferably within pharmaceutical or related industries.
• Strong understanding of various quality and operational systems supporting facility, equipment, utilities, and computer systems.
• Solid working knowledge of cGMP regulations and industry documentation standards.
• Proficient in Microsoft Office Suite.
• Excellent oral and written communication skills.

Responsibilities

• Supporting CAPA activities within the Global Engineering Services (GES) organization
• Contributing to GES compliance and validation programs by maintaining records, preparing metrics, and tracking action items
• Assisting with internal, Corporate, Divisional, Regulatory, and third-party audits related to GES
• Write, review, approve and/or execute documentation for new and current validation procedures and technical reports related to qualified facilities/utilities/equipment, validated spreadsheets, validated systems, and/or validated processes.
• Represent division, department, and group interests as a QA Validation Representative in meetings, conference calls, or as needed.
• Ensure compliance with division, corporate, and regulatory requirements by providing quality guidance to customers and clients on policies and procedures related to development and validation.
• Provide support to ensure that Departmental Validation Master Plans are developed, approved in a timely manner, and adhered to.
• Investigate/troubleshoot validation problems for qualified facilities/utilities/equipment, validated spreadsheets, validated systems, and/or validated processes.
• Abbott Engineering Standards (AES) committee member
• Develop and evaluate quality process and system standards to ensure compliance with company standards and regulatory requirements.
• May assist with establishing and updating corporate validation policies.
• Conduct External Supplier Evaluations and manage the Approved Supplier List.

Benefits

• 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.

What This Job Offers

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