Posted:
10/3/2024, 9:14:14 AM
Location(s):
Columbus, Ohio, United States ⋅ Ohio, United States
Experience Level(s):
Senior
Field(s):
Legal & Compliance
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:
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 : Bachelors 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: www.abbottbenefits.com
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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews
The base pay for this position is
$72,700.00 – $145,300.00In specific locations, the pay range may vary from the range posted.
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Website: https://abbott.com/
Headquarter Location: Illinois City, Illinois, United States
Employee Count: 1001-5000
Year Founded: 1944
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Emergency Medicine ⋅ Genetics ⋅ Health Care ⋅ Health Diagnostics ⋅ Manufacturing ⋅ Medical ⋅ Medical Device ⋅ Nutrition ⋅ Pharmaceutical