AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The QA CAPA Analyst position supports the activities and initiatives of the Quality Manager to implement and manage the Quality System. This includes support on: exception reports, policy &procedure, program management, internal/external audit, and metrics and trend analysis and reporting.
- Review and approve, as appropriate, CAPA, Change Control and Risk Management related documentation.
- Monitor the performance of the site through appropriate Key Performance Indicators (KPIs) for CAPA, Change Control, and Risk Management. Ensure a timely completion of actions identified in Exception Reporting System, Change Management or Risk Management quality records and programs.
- Provide leadership to ensure that actions are properly reviewed with management to ensure appropriate definition and timely completion of actions and review of significant trends/issues. Evaluate if actions were effective and verified after implementation. Confirm that actions do not adversely affect manufactured product.
- Maintain the required databases necessary for tracking and trending to ensure actions are implemented and documented.
- Facilitate site meetings to ensure timely identification and management of site events, including but not limited to triage and CAPA review. Drive dialogue and discussion to ensure non-conformances are appropriately documented in a timely manner and that - when required - investigations are timely, rigorous and drive to root cause to facilitate the identification and implementation of effective corrections, corrective and preventive actions.
- Provide in a timely manner information and analysis required for the Product Quality Reviews, monthly PIT, Monthly and Quarterly Management Reviews, as well as ad hoc metrics for processes owned by QA Shared Services team.
- Review and perform statistical analysis of all exception documents by reasons (re-inspections, NCR, Deviations and associated formal investigations). Correlate information and summarize it with the corresponding corrective actions. Identify if there are trends indicating the need for changes manufacturing or control procedures.
- Serve as site CAPA SME.
- Bachelor’s degree in Natural Sciences, preferable Biology, Chemistry, or related field
- Minimum of 2 years’ experience in a Quality related field
- Quality/compliance management skills as well as regulations and standards.
- Computer literacy to manage multiple computer programs and databases (e.g. Word, Excel, PowerPoint), required.
- Knowledge of data processing system, analytical competence, good verbal and written communication skills in both languages, English and Spanish.
- Prior experience in CAPA, Change Control, and/or Risk Management is preferred.
- Good oral, written, and presentation skills
- Sound decision making and problems solving skills to assure business unit compliance
- Strong analytical skills, ability to analyze data and trends and draw conclusions
- Good mathematics background with an understanding of basic statistical concepts
Significant Work Activities: N/A
Job Type: Experienced