Quality Assurance Analyst I — CAPA, Change Control & Risk

Weil Group, Inc; Barceloneta (PR); On-site; USD 60,000 - 85,000; Full time

Job summary

Weil Group, Inc. is seeking an Associate Quality Analyst to lead nonconformance, CAPA, Change Control and Risk Management activities in our biopharma operations.

The role requires strong analytical skills, bilingual English/Spanish communication, and experience with QA systems and regulatory compliance to prevent failures and support continuous improvement. You will monitor KPIs and facilitate reviews to ensure timely actions and regulatory readiness across manufacturing and quality

Qualifications

• Bachelor’s degree in Natural Sciences or related field.
• Experience in quality/compliance management in pharma/biotech preferred.
• Knowledge of CAPA, Change Control, and Risk Management.
• Strong written and verbal communication in English and Spanish.

Responsibilities

• Monitor KPIs for CAPA, Change Control, and Risk Management.
• Lead actions to ensure timely completion and prevent regulatory liabilities.
• Maintain databases for tracking and trending quality actions.
• Facilitate CAPA reviews and investigations to identify root causes.
• Prepare information for Annual Quality Reviews and other meetings.
• Analyze exception documents and summarize corrective actions.

Skills

Bilingual EN/ES

Analytical skills

Problem solving

Interpersonal skills

Education

Bachelor’s degree in Natural Sciences or related field

Job description

Weil Group, Inc. is seeking an Associate Quality Analyst to lead nonconformance, CAPA, Change Control and Risk Management activities in our biopharma operations.

The role requires strong analytical skills, bilingual English/Spanish communication, and experience with QA systems and regulatory compliance to prevent failures and support continuous improvement. You will monitor KPIs and facilitate reviews to ensure timely actions and regulatory readiness across manufacturing and quality