Associate Quality Analyst, CAPA & Change Control

Veg Group; Northern (KY); Hybrid; USD 45,000 - 62,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking an Associate Quality Analyst to support CAPA, Change Control and Risk Management within the pharmaceutical and biotechnology industries.

This role emphasizes quality compliance, data management, and rigorous documentation. The ideal candidate holds a natural sciences degree, appreciates regulatory standards, and can communicate effectively in English and Spanish.

Qualifications

• Bachelor's degree in Natural Sciences, preferably 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 skill in both languages, English and Spanish.
• Prior experience in CAPA, Change Control, and/or Risk Management is preferred.

Responsibilities

• Monitor performance through appropriate KPIs for CAPA, Change Control, and Risk Management.
• Provide leadership to ensure actions are properly reviewed and timely completed.
• Evaluate if actions were effective and verified after implementation.
• Maintain databases for tracking and trending of actions.
• Facilitate meetings to ensure timely identification and management of events.
• Drive documentation of non-conformances and investigations to root cause.
• Provide analysis required for Annual Quality Reviews and other meetings.
• Review and perform statistical analysis of exception documents and summarize corrective actions.

Skills

Quality management

CAPA

Change Control

Risk Management

Regulatory standards

English & Spanish communication

Computer literacy

Education

Bachelor’s degree in Natural Sciences

Job description

Validation & Engineering Group, Inc. (V&EG) is seeking an Associate Quality Analyst to support CAPA, Change Control and Risk Management within the pharmaceutical and biotechnology industries.

This role emphasizes quality compliance, data management, and rigorous documentation. The ideal candidate holds a natural sciences degree, appreciates regulatory standards, and can communicate effectively in English and Spanish.