CAPA Specialist Columbus, OH Plant

4 weeks 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.

Job Summary

The CAPA Process Analyst I will progress investigations through the CAPA system in support of non-CAPA organizations. This role will work closely with other functional areas 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.

Key Responsibilities
  • Evaluate 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 division's Quality System.
  • Facilitate the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
  • Maintain 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.
  • Support a work environment that ensures team effectiveness by demonstrating full cross-functional team support that complies with Corporate and regulatory requirements.
Requirements
  • Associates Degree (± 13 years) or an equivalent combination of education and work experience: Bachelors Degree (± 16 years)
  • Minimum 2 years 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.
About Abbott

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.

Nourish the world and your career as part of the Nutrition team at Abbott. Our 114,000 colleagues serve people in more than 160 countries.

Columbus, Ohio, is Abbott's first manufacturing facility in the world, making us a leader in science-backed nutrition products. Working here, you'll be part of a family that works together to produce quality products that make a difference and help keep consumers nourished at every stage of their lives.

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

  • 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
  • Free medical coverage for employees via the Health Investment Plan (HIP) PPO
  • 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 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.
  • A stable company with a record of strong financial performance and history of being actively involved in local communities.

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