Quality Assurance Analyst II - Process & Compliance

PRPDG; Juncos (PR); On-site; USD 55,000 - 75,000; Full time

Job summary

PRPDG is seeking a Quality Assurance professional to monitor quality detractors across service and complaint databases, ensuring compliance with policies, procedures, and safety regulations. You will develop solutions to database issues, write and support SOPs, and analyze significant quality trends with cross-functional teams.

The role supports product review and release activities, generates quality reports, and assists GMP auditing activities.

Qualifications

• Bachelor's degree or equivalent in a related field.
• 2-4 years of relevant QA or regulated manufacturing experience.
• Experience in investigations and complaints strongly preferred.
• Strong analytical, problem-solving, documentation, and communication skills.
• Ability to work effectively with cross-functional teams.

Responsibilities

• Monitor and track quality detractors through service and complaint databases.
• Ensure compliance with company policies, procedures, quality standards, and applicable safety and environmental regulations.
• Develop solutions to database issues of moderate scope and complexity.
• Write and support the development of Standard Operating Procedures (SOPs).
• Identify and analyze significant quality trends and report findings to management and cross-functional teams.
• Provide technical support in the use of information mapping technology.
• Support product review and release activities.
• Generate moderately complex statistical summaries and quality reports.
• Provide support for GMP auditing activities.

Skills

Analytical skills

Documentation

Communication skills

Cross-functional teamwork

Education

Bachelor's degree

Job description

PRPDG is seeking a Quality Assurance professional to monitor quality detractors across service and complaint databases, ensuring compliance with policies, procedures, and safety regulations. You will develop solutions to database issues, write and support SOPs, and analyze significant quality trends with cross-functional teams.

The role supports product review and release activities, generates quality reports, and assists GMP auditing activities.