Senior Auditor Regulatory Compliance Specialist

4 weeks ago

Columbus, Ohio, United States Abbott Laboratories company Full time

Abbott Laboratories 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.

Nourish the world and your career as part of the Nutrition team at Abbott.

Abbott's Nutrition Division 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 get the nutrients they need to live their healthiest life.

Columbus, Ohio, is Abbott's first manufacturing facility in the world, making us a leader in science-backed nutrition products. Working here, you'll be part of a family that works together to produce quality products that make a difference and help keep consumers nourished at every stage of their lives.

WHAT WE OFFER AT ABBOTT

At Abbott, you can have a good job that can grow into a great career. We offer:

  • 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
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • 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 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.
  • A stable company with a record of strong financial performance and history of being actively involved in local communities.

WHAT YOU'LL WORK ON

MAIN PURPOSE OF ROLE

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.

MAIN RESPONSIBILITIES

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 requested.

Presents results of audits to senior management such as during periodic quality system reviews.

Serves as point-of-contact for regulatory agency inspections or assessments.

Works with Regulatory Compliance Management to develop the annual audit schedule, assignments, and budgetary impact.

Provides input to Regulatory Compliance Management regarding Lead Auditor performance.

EDUCATION AND EXPERIENCE YOU'LL BRING

Education

Education Level: Bachelor's Degree (16 years)

Major/Field of Study: National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline.

OR

An equivalent combination of education and work experience.

Learn more about our benefits that add real value to your life to help you live fully:

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity and a Military/Veteran friendly Employer, committed to employee diversity.

Connect with us at, on Facebook at and on Twitter @AbbottNews

The base pay for this position is $72,700.00 $145, In specific locations, the pay range may vary from the range posted.

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