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CAPA Coordinator

Company: Abbott Laboratories
Location: Mishawaka
Posted on: September 22, 2022

Job Description:

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.Nourish the world and your career as part of the Nutrition team at Abbott.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 , Glucerna and ZonePerfect - to help get the nutrients they need to live their healthiest life.WHAT YOU LL DOThe CAPA Coordinator QA progresses investigations through the CAPA system. Works closely with other functional areas with the use of investigational tools to determine the root cause of any nonconformity, ensures that CAPA plans address root causes, and ensures that corrective actions and preventative actions are implemented to facilitate the rapid, compliant, introduction of new/improved products, processes, and systems. Works to ensure that actions are on time, thorough, complete, meet the needs of the business and customers and that required standards and/or procedural requirements are met. Be an effective member of a multifunctional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct.WHAT WE OFFERAt 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% 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: MAIN RESPONSIBILITIES INCLUDE: Evaluates and progresses the timely completion of CAPA system activities, including effectiveness checks, raised for non-conformances, potential non-conformances, and/or deviations, as output from ADC s Quality System. Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance. Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area. Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner. Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements. Supports other organizations in the management of their CAPA actions and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner; and that viable corrective actions are identified and implemented to address any non-conformances.EDUCATION AND EXPERIENCE Associate's Degree or high school diploma with equivalent with 2 years CAPA work experience in manufacturing plant environment. Minimum 2 years experience in regulated, manufacturing environment. Knowledge of FDA Quality System Regulations is preferred. Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted. Good project management skills to deliver an effective service in a timely manner. Attention to detail to ensure accuracy of work that forms part of the Quality System documentation. Good written and oral communication skills to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization. Able to work independently.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 Employer, committed to employee diversity. Connect with us at , on Facebook at and on

Keywords: Abbott Laboratories, Mishawaka , CAPA Coordinator, Other , Mishawaka, Indiana

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