Analyst 2 Quality Assurance

Juncos - Puerto Rico

Monthly Salary: Not Disclosed

Experience Required: 3years

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

The Analyst II Quality Assurance is responsible for establishing and maintaining quality assurance programs procedures and controls to ensure product integrity and regulatory compliance. This role focuses on monitoring performance parameters across products and quality system elements identifying trends and driving continuous improvement initiatives.

Duties & Responsibilities

Preferable experience with investigations and complains.

Monitor and track quality detractors using service and complaint databases.

Ensure compliance with company policies procedures and applicable quality safety and environmental standards.

Develop solutions to database-related issues of moderate scope and complexity.

Write and assist in the development of standard operating procedures (SOPs).

Analyze data to identify significant trends and report findings to management and cross-functional teams.

Provide advanced technical support in the use of information mapping technologies.

Support product review and release activities.

Generate moderately complex statistical summaries to support quality reporting.

Assist in Good Manufacturing Practice (GMP) audits and related compliance activities.

Requirements

Bachelors degree in a scientific engineering or related discipline (or equivalent).

24 years of relevant work experience in quality assurance or quality systems.

Preferred Skills

Strong understanding of GMP and pharmaceutical regulatory requirements.

Experience with complaint handling systems and service databases.

Proficiency in statistical analysis and trend identification.

Excellent communication (English/Spanish) and documentation skills.

The Analyst II Quality Assurance is responsible for establishing and maintaining quality assurance programs procedures and controls to ensure product integrity and regulatory compliance. This role focuses on monitoring performance parameters across products and quality system elements identifying t...