Site Capa Coordinator

3 weeks ago

Casa Grande, United States Abbott Laboratories Full time

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.

**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 plan
- ** 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 Casa Grande, Arizona 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.

**Casa Grande, Ariz., **is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment to innovation and excellence. But we’re more than just a company, we’re a family. Working here you’ll be part of a family that works together to make a difference and enhance the lives of millions worldwide.

**What You’ll Work On**

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

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