Note: The job is a remote job and is open to candidates in USA. Validation & Engineering Group, Inc. provides services and solutions for the pharmaceutical, biotechnology, chemical, food, and medical device industries. The Associate Quality Analyst I will manage nonconformance, CAPA, Change Control, and Risk Management activities, including monitoring KPIs, facilitating quality meetings, maintaining tracking databases, and performing statistical analysis to identify trends and support effective corrective actions.
Responsibilities
- Monitor performance 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 in order to ensure appropriate definition and timely completion of actions and review of significant trends/issues to prevent regulatory liabilities and financial losses. Evaluate if actions were effective and verified after implementation. Confirm that actions do not adversely affect the finished product
- Maintain the required databases necessary for tracking and trending to ensure actions are implemented and documented
- Facilitate meetings to ensure timely identification and management of events, including but not limited to triage and CAPA review board. 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 Annual Quality Reviews, among other meetings
- 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
Skills
- * Bachelor's degree in Natural Sciences, preferrably Biology, Chemistry or related field
- * Technical Writing skills and investigations processes
- * Available to work extended hours, possibility of weekends and holidays
- * Must be fully bilingual (English / Spanish) with excellent oral skills
- * Good verbal and written communication skills in both Spanish and English
- * Good problem solving and analytical skills
- * Good interpersonal relations / communications skills
- * Good negotiation skills
- * This position requires knowledge in: quality / compliance management, visual inspection AQL and operator certification processes, aseptic processing operations, as well as regulations and standards affecting Biologics and Parenteral applications
- * Quality/compliance management skills as well as regulations and standards
- * Position requires computer literacy to manage multiple computer programs and databases
- * Knowledge of data processing system, analytical competence, good verbal and written communication skills in both languages, English and Spanish
- * Experience in a Quality or technical field in the Pharmaceutical or Biotechnological industry preferred
- * Prior experience in CAPA, Change Control, and/or Risk Management is preferred
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