CAPA Specialist

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. JOB DESCRIPTION: Nourish the world and your career as part of the Nutrition team at Abbott. Abbotts 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.. WHAT WE OFFER AT ABBOTT At Abbott, you can have a good job that can grow into a great career. We offer: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution. Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelors degree. A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. WHAT YOULL WORK ON The CAPA Specialist: Progresses investigations through the CAPA system in support of non-CAPA organizations. Works closely with other functional areas with the use of investigational tools, to determine the root cause of any nonconformity, ensure that CAPA plans address root causes, and ensure that CA/PAs 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. Is an effective member of a multifunctional team, ensuring that all communications, interpersonal interactions, and business behaviors are consistent with the Abbott Code of Conduct. MAIN RESPONSIBILITIES Evaluates and progress the timely completion of CAPA system activities, including effectiveness checks, raised for nonconformances, potential non-conformances, and/or deviations, as output from the divisions 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. Ensure 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 the attainment of division goals and objectives. Accountable to the Quality Organization for achieving mutually agreed upon objectives. 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. The CAPA System is a key inspection focus of worldwide regulators and auditors. The system must be usable, simple, sustainable and well maintained. Failure to comply with the primary objectives of this role can result in negative impact to the business such as observations, warning letters, de-certification, or product recalls. Decisions and recommendations made by this position impact quality decisions for marketed products and the divisions Quality System. EDUCATION AND EXPERIENCE YOULL BRING Minimum of two (2) years of experience working in a regulated environment or experience performing investigations. Knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 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. 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 $60,000.00 $120,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Operations Quality DIVISION: ANSC Nutrition Supply Chain LOCATION: United States > Sturgis : Building 01A ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day) 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 Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions across the spectrum of health, around the world, for all stages of life. Whether its next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of lifes greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter