Senior Quality Assurance Specialist

3 days ago

Columbus, Ohio, United States Abbott Laboratories Full time
About Abbott Laboratories

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 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, Protality and Glucerna – to help get the nutrients they need to live their healthiest life.

Job Summary

We are seeking a highly skilled Senior Specialist Quality Assurance – Ingredient Supplier Quality to join our team. This role will be responsible for managing projects and responsibilities of a potentially complex nature, including providing support to AN manufacturing plants by resolving incoming material issues in a timely manner, leading supplier event management activities to troubleshoot and resolve supplier processing or ingredient issues, and monitoring supplier performance on an on-going basis and initiating supplier improvement activities, when needed.

Key Responsibilities
  • Provide support to AN manufacturing plants by resolving incoming material issues in a timely manner
  • Lead supplier event management activities to troubleshoot and resolve supplier processing or ingredient issues
  • Support and influence suppliers to drive to root cause and implement effective CAPA when issues arise
  • Monitor supplier performance on an on-going basis and initiate supplier improvement activities, when needed
  • Utilize supplier development tools to assess, create action plans, and work with suppliers to improve performance
  • Initiate, write and support issuance of quality reports to assist the AN plants in accepting and utilizing ingredients, as necessary
  • Ensure that proposed changes to supplier processes or ingredients are assessed, approved and compliant to specifications, and make changes when necessary
  • Responsible for maintaining/controlling the status of ingredient suppliers
  • Support supplier certification program activities
  • Maintain GSQA policies and procedures, ingredient specifications and acceptance plans, and ensure that these documents are current and compliant to internal policies and regulations
  • Lead strategic projects to support department and organization initiatives and goals
  • Responsible for ingredient supplier qualification activities
  • Perform supplier audits including qualification and for-cause audits
Requirements
  • Bachelor's Degree in physical or life science, engineering or business, or a related degree
  • 8 years or more of experience in supplier quality assurance programs or related experience in operations, purchasing or quality assurance in a regulated industry
  • Thorough knowledge of manufacturing processes (production, logistics, and engineering) and quality assurance principles
  • Technical understanding of different technologies, product quality systems and supplier programs, and be able to provide consultation and recommendations to help suppliers improve their performance
  • Experience in performing/leading supplier audits and working independently through troubleshooting supplier issues
Preferred Qualifications
  • Master's Degree
  • Ability to work independently and/or function with minimal supervision
  • Ability to manage several activities/projects at once, to organize/prioritize work, to meet deadlines and to prepare plans and reports
  • Ability to maintain a high degree of accuracy and analytical thinking
  • Ability to effectively organize and communicate technical information
  • Ability to successfully interact and communicate with internal and external cross-functional teams, and all organizational levels
Travel
  • 10% of the time

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