CAPA Specialist Day Shift Columbus OH Plant

2 days ago

Columbus, Ohio, United States Abbott Full time
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.

Job Summary

We are seeking a skilled CAPA Specialist to join our team in Columbus, Ohio. As a key member of our Quality Organization, you will be responsible for progressing investigations through the CAPA system, working closely with other functional areas to determine the root cause of nonconformities, and ensuring that CAPA plans address root causes.

Key Responsibilities
  • Evaluate and progress the timely completion of CAPA system activities, including effectiveness checks, raised for nonconformances, potential non-conformances, and/or deviations.
  • 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 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.
What We Offer

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.
  • 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.
Join Our Team

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.

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