Quality Analyst I — CAPA, Change Control & Risk Mgmt

Validation-; Barceloneta (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks an Associate Quality Analyst I to drive quality processes, CAPA, change control, and risk management in a regulated setting. The role emphasizes leadership in nonconformance handling and data-driven improvement.

The candidate will monitor KPIs, maintain tracking databases, and support annual quality reviews. English and Spanish communication, plus strong technical writing and regulatory knowledge, are required.

Qualifications

• Bachelor’s degree in Natural Sciences, preferrably Biology, Chemistry or related field.
• Experience in a Quality or technical field in the Pharmaceutical or Biotechnological industry preferred.
• 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.
• Prior experience in CAPA, Change Control, and/or Risk Management is preferred.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• 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.
• Technical Writing skills and investigations processes.
• Good problem solving and analytical skills.
• Good interpersonal relations / communications skills.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• Provide leadership and direction in all aspects of quality processes that manage nonconformance and CAPA, Change Control and Risk Management.
• Monitor performance through appropriate KPIs for CAPA, Change Control, and Risk Management. Ensure timely completion of actions in quality records and programs.
• Provide leadership to ensure actions are properly reviewed and completed, and review significant trends/issues to prevent regulatory liabilities.
• Maintain databases for tracking and trending to ensure actions are implemented and documented.
• Facilitate meetings to ensure timely identification and management of events, including CAPA review board and investigations.
• Provide information and analysis for the Annual Quality Reviews and other meetings.
• Review and perform statistical analysis of exception documents by reasons and identify trends for remediation.

Skills

Quality management

Analytical skills

Technical writing

Bilingual English/Spanish

Education

Bachelor’s degree in Natural Sciences (Biology or Chemistry)

Tools

MS Windows

Microsoft Office

Job description

Validation & Engineering Group, Inc. seeks an Associate Quality Analyst I to drive quality processes, CAPA, change control, and risk management in a regulated setting. The role emphasizes leadership in nonconformance handling and data-driven improvement.

The candidate will monitor KPIs, maintain tracking databases, and support annual quality reviews. English and Spanish communication, plus strong technical writing and regulatory knowledge, are required.