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CAPA Specialist Day Shift Columbus, OH Plant
1 month ago
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 SummaryThe 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 implement corrective actions 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.
- 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.
- 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.
This role is an excellent opportunity to join a dynamic team and contribute to the success of Abbott's Nutrition Division. As a CAPA Process Analyst I, you will play a critical role in ensuring the quality and compliance of our products and processes.
What We Offer- Competitive compensation and benefits package.
- Opportunities for professional growth and development.
- A collaborative and supportive work environment.
- Recognition and rewards for outstanding performance.
If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter to [insert contact information].
