Senior Auditor Regulatory and Compliance - Altavista, VA Plant

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.

     

JOB DESCRIPTION:

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:

• Production areas that are clean, well-lit and temperature-controlled
• 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, Medical Benefits start day 1
• Vacation – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
• Retiree Healthcare program
• Robust 401(k) retirement savings with a generous company match
• 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 stable company with a record of strong financial performance and history of being actively involved in local communities
• 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

This position works out of our Altavista, VA location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

Altavista, Va., is one of Abbott’s largest nutrition manufacturing plants equipped with advanced technology to ensure efficient production. Working here will make you feel like you’re part of a family that works together to make a difference and help nourish millions of families around the world.

The Regulatory Compliance Auditor performs assessments of the Division quality systems worldwide to determine whether the quality system is in compliance with the established requirements and to evaluate its effectiveness.

What You’ll Work On

• Audits areas of the Division quality system, such as development and manufacturing, as assigned.
• Creates audit checklists based on assigned area, applicable regulations, and pertinent Division quality system/procedural requirements, and obtains approval from Lead Auditor as appropriate.
• Evaluates the adequacy and compliance of systems, operations, and practices against regulations and company documentation.
• Formulates and documents nonconformity and obtains concurrence with responsible management .
• Tracks issues through to closure including reviewing the corrective action taken.
• Develops an audit plan including scope and objective and obtains management approval.
• Provides work direction to audit team.
• Communicates final results of audits to responsible management during formal management debriefs.
• Writes reports of audit results, obtains approval, and publishes results to responsible management.
• Oversees follow-up of corrective actions and audit closure, including escalating overdue items as necessary.
• Serves as escort to inspectors or assessors from regulatory agencies or notified bodies .
• Provides input to Regulatory Compliance Management on audit staff performance.
• As requested, coordinates product actions (for example recalls) with manufacturing units and affiliates.
• As requested, communicates product actions and subsequent updates to regulatory bodies.
• Serves as quality system expert resource to management and to other business units as