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Site CAPA Coordinator

Location
Stanfield, Arizona
Job Type
Permanent
Posted
8 Sep 2022

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 113,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

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®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.

WORKING AT ABBOTT

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

  • Fast paced work environment where your safety is our priority
  • 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 - 3 weeks accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays
  • Company Paid Pension Plan
  • 401(k) retirement savings with a generous company match of 5%
  • 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.
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities
  • Learn more about our benefits that add real value to your life to help you live fully: 

The Opportunity - Site CAPA Coordinator

This position works out of our Casa Grande, AZ location in the Abbott Nutrition Division.   Casa Grande, Ariz., is one of six Abbott nutrition manufacturing plants in the U.S., with about half of its products exported around the world. Working here, you'll feel part of a family - a family of 480+ that works together to help nourish the world.

WHAT YOU'LL DO: 

The primary responsibilities of the CAPA Coordinator are multifunctional and include management of the plant GMP/Investigations and Corrective Action/Preventative Action (CAPA) program.  Primary responsibilities include implementation and maintenance in the following areas:

  • Responsible for the review of investigations and writing complex investigations.
  • Responsible for leading Root Cause Analysis, corrective and preventative action (CAPA).
  • Technical resource for Root Cause Analysis.
  • Training on the investigation/CAPA system
  • The CAPA Coordinator reports to the Manager, Plant Quality Systems.  The CAPA Coordinator's responsibility impacts all nutritional products produced in the plant and the preservation of the company's continued well-being through compliance to regulations and avoidance of major business interruptions from regulatory agencies such as the FDA.  This position is responsible for all investigations, compliance to company policies, procedures, and established regulatory standards.  This position requires a high degree of independence and must perform all tasks with minimum supervision.

Major Responsibilities:

 

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • The CAPA Coordinator is responsible for implementing, maintaining and monitoring the effectiveness of the CAPA Quality System.
  • Assembles CAPA information for monthly and quarterly management review presentations to the plant staff.  Reports required metrics to all levels of the organization.
  • Monitors and analyzes plant CAPA metrics and program trend analysis.  Ensure all deadlines are met for action items.
  • Reviews non-conformances that impact product quality and provides recommendations and corrective actions and effectiveness plans.   
  • Ensures that investigation/CAPA documentation is compliant with GMP, industry standards, Division and Corporate policy/procedure requirements. 
  • Ensure investigations are approved by correct areas.
  • Assists manufacturing and other departments in identifying root cause and implementing effective corrective and preventative actions for those circumstances where quality standards are not met. 
  • Training of personnel on the CAPA system.
  • Oversees and leads Site PoP (Protect Our Product) Program. Provides mentoring to PoP Workstream Leads and acts as a liaison between Division and the Site.

WHAT YOU'LL BRING:

EDUCATION/EXPERIENCE:

  • Bachelor's Degree required.  Preferably in Business, Science, Engineering, Math/statistics or equivalent experience. Master's Degree preferred.

EXPERIENCE:

  • Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.
  • Four+ years quality assurance experience in a GMP industry preferred. 
  • Knowledge of applicable regulatory standards and requirements for infant formula and medical nutritional products required.  Knowledge of food processing techniques, laboratory procedures, documentation requirements and statistical applications is essential.
  • Must have strong written and verbal communication skills.  Must be organized and able to prioritize duties and responsibilities.  Must demonstrate initiative, innovation, critical thinking and sound analytical problem-solving skills.  Must be able to interact with all levels and disciplines of employees.  Must be able to manage multiple, high priority projects.

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* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: 

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity and a Military/Veteran Friendly employer.

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

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Details

  • Job Reference: 707210691-2
  • Date Posted: 8 September 2022
  • Recruiter: Abbott Laboratories
  • Location: Stanfield, Arizona
  • Salary: On Application
  • Sector: Manufacturing Operations
  • Job Type: Permanent