Quality Assurance Analyst I: CAPA, Change Control

Artech-Information-Systems-L.l.c.; Barceloneta (PR); Presencial; USD 28 000 - 33 000; Tempo integral

Resumo da oferta

Artech-Information-Systems-L.l.c. is seeking an Associate Quality Analyst I for Barceloneta, PR to support CAPA, Change Control and Risk Management in a biologics/parenteral setting.

The role emphasizes quality and compliance, data tracking, and cross-functional collaboration across Spanish and English speakers. The position requires a Bachelor’s in Natural Sciences or related field, with experience in quality/compliance processes, CAPA, and Change Control.

Qualificações

• Must have strong verbal and written communication in English and Spanish
• Strong analytical and problem-solving abilities
• Effective interpersonal and negotiation skills
• Ability to work in a regulated quality environment

Responsabilidades

• Monitor KPIs for CAPA, Change Control and Risk Management and drive timely actions
• Lead and review actions to ensure proper definition, timely completion and root-cause analysis
• Ensure actions do not adversely affect finished products
• Maintain databases for tracking and trending of actions
• Facilitate CAPA review boards and keep investigations timely, rigorous and effective
• Provide information and analyses for Annual Quality Reviews and other meetings
• Perform statistical analysis of exception documents and summarize with corrective actions

Descrição da oferta de emprego

Artech-Information-Systems-L.l.c. is seeking an Associate Quality Analyst I for Barceloneta, PR to support CAPA, Change Control and Risk Management in a biologics/parenteral setting.

The role emphasizes quality and compliance, data tracking, and cross-functional collaboration across Spanish and English speakers. The position requires a Bachelor’s in Natural Sciences or related field, with experience in quality/compliance processes, CAPA, and Change Control.