Abbott CAPA Process Analyst II - Abbott Diabetes Care in Alameda, California

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

PRIMARY FUNCTION:

The CAPA Process Analyst II:

  • Progresses investigations and other activities through the CAPA program.

  • Leads cross-functional teams in the use of investigational tools to determine the root cause of nonconformities, ensures that CAPA plans address root causes, and that CA/PAs are implemented timely to facilitate the rapid and compliant introduction of new/improved products, processes, and systems.

  • Ensures that actions are on time, thorough, complete, and meet the needs of the business and customers, and that required standards and/or procedural requirements are met.

  • Leads a multifunctional team, ensuring that all communications, interpersonal interactions and business behaviors are consistent with the Abbott Code of Conduct.

MAJOR RESPONSIBILITIES:

  1. Leads the investigation of complex and highly technical quality issues to ensure the timely completion of CAPA system activities raised for nonconformance’s, potential nonconformance’s, CAPAs, deviations, and/or complaint investigations.

  2. Is a subject matter expert on investigation and root cause analysis techniques to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.

  3. Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area. Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.

  4. Produces trending metrics and reports to identify, prioritize and manage further actions, as may be required. Provides leadership for the initiation of improvement activities associated with identified trends.

  5. Is an active leader supporting a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements. Ensures effective written and verbal communications.

  6. Prioritizes workload in relation to the needs of the business.

  7. Supports the attainment of ADC goals and objectives.

MINIMUM EDUCATION REQUIRED:

Bachelor degree or equivalent experience (i.e. minimum of 4 year’s work experience in the medical device/pharma/biotech industry).

MINIMUM EDUCATION REQUIRED:

1.Minimum of four (4) years of experience working in a regulated environment or experience performing investigations.

2.Good working knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 preferred.

3.Good working knowledge of investigational and Root Cause Analysis Techniques.

4.Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.

5.Good technical writing and oral communication skills are required to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization. 6. Must be able to work independently.

ACCOUNTABILITY / SCOPE/BUDGET:

Accountable to the Quality Organization for achieving mutually agreed upon objectives. Influence and visibility extend beyond immediate organization, including ADC Divisional Management. Position involves interactions across multiple functional areas including operations, R&D, Marketing, Supply Chain, Quality and Regulatory. 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 the quality of marketed products and the effectiveness of ADC’s Quality System to applicable regulations.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com