ABBOTT LABORATORIES Corrective Action Preventative Action Analyst I Salary in the United States

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 103,000 colleagues serve people in more than 160 countries.

The CAPA Process Analyst I: 
•    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 multi-functional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct.
 

Responsibilities:
Evaluates and progress 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 non-conformance.
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 ADC goals and objectives.

Qualifications:
Associate degree or equivalent experience (i.e. minimum of 2 year’s work experience in the medical device/pharma/biotech industry). Bachelor degree preferred. 
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.