Associate Quality Analyst
On-siteBarceloneta, Barceloneta, Puerto Rico
Job Summary
Monitor performance through Key Performance Indicators for CAPA, Change Control, and Risk Management, ensuring timely completion of actions in quality records and programs. Provide leadership to review actions, analyze trends, and prevent regulatory liabilities while evaluating effectiveness after implementation. Maintain databases for tracking and facilitate meetings for triage and CAPA review boards. Drive discussions to document non-conformances, conduct rigorous investigations to root causes, and perform statistical analysis of exception documents to identify trends requiring procedure changes. Support Annual Quality Reviews with required information and analysis.
Required Qualifications
- Bachelor's degree in Natural Sciences, preferably Biology, Chemistry or related field
- Position requires computer literacy to manage multiple computer programs and databases
- Knowledge of data processing system
- Analytical competence
- Good verbal and written communication skill in both languages, English and Spanish
Desired Qualifications
- Experience in a Quality or technical field in the Pharmaceutical or Biotechnological industry preferred
- Quality/compliance management skills as well as regulations and standards
- Prior experience in CAPA, Change Control, and/or Risk Management is preferred
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