QA Complaints Investigator — CAPA & Data Trends

FITS LLC; Gurabo (PR); On-site; USD 48,000 - 70,000; Full time

Job summary

FITS is seeking a detail-oriented Quality Assurance professional to ensure regulatory compliance and data integrity across pharmaceutical, medical device, and biotech processes. You will participate in investigations, CAPA, trend analysis, and SOP development while supporting GMP audits and product release activities.

The role emphasizes root cause analysis, data-driven decision making, and collaboration with cross-functional teams to maintain high-quality research and services.

Qualifications

• Bachelor's degree in Science, Engineering, or related field (or equivalent).
• 2–4 years of experience in Quality Assurance within regulated industry (pharmaceutical, biotech, or medical device).
• Working knowledge of cGMP, FDA regulations, and data integrity principles (ALCOA+).

Responsibilities

• Monitor and track quality detractors using service and complaint databases.
• Support complaint investigations and drive timely closure.
• Identify significant trends and report to management and cross-functional teams.
• Generate moderately complex statistical summaries to support quality decisions.
• Develop solutions to database issues of moderate scope and complexity.
• Write SOPs and assist others in writing and revising them.
• Provide advanced technical support on information mapping tools.
• Support product review and release functions.
• Support GMP audits and inspection readiness.
• Ensure compliance with company policies, procedures, quality standards, and safety and environmental regulations.

Skills

Quality Assurance

cGMP

FDA regulations

ALCOA+

Root cause analysis

CAPA

SOP writing

GMP audit support

Data integrity

Statistical analysis

Education

Bachelor's degree in Science/Engineering or related field

Tools

Information mapping tools

Complaint databases

Job description

FITS is seeking a detail-oriented Quality Assurance professional to ensure regulatory compliance and data integrity across pharmaceutical, medical device, and biotech processes. You will participate in investigations, CAPA, trend analysis, and SOP development while supporting GMP audits and product release activities.

The role emphasizes root cause analysis, data-driven decision making, and collaboration with cross-functional teams to maintain high-quality research and services.