Quality Complaints & CAPA Investigator

fitspr; Gurabo (PR); On-site; USD 55,000 - 85,000; Full time

Job summary

FITS is seeking a Quality Assurance professional in the Puerto Rico/United States region to oversee product complaints, investigations, and CAPA processes. The role requires 2–4 years in QA within regulated industries and solid knowledge of cGMP and FDA regulations, including data integrity (ALCOA+).

The candidate will monitor detractors, support investigations, identify trends, and assist with SOPs, GMP audits, and release activities, ensuring compliance across the organization.

Qualifications

• Bachelor's degree in Science, Engineering, or related field; 2–4 years of QA in a regulated industry (pharmaceutical, biotech, or medical device).
• Working knowledge of cGMP, FDA regulations, and data integrity principles (ALCOA+).
• Shift: 1st, 2nd, and 3rd shifts as needed.

Responsibilities

• Monitor and track quality detractors using service and complaint databases.
• Support complaint investigations and help drive them to 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 knowledge

FDA regulations

Data integrity (ALCOA+)

Root cause analysis

CAPA

SOP writing

GMP audit support

Product complaint handling

Data analysis

Education

Bachelor's degree in Science/Engineering or related field

Tools

Complaint databases

Information mapping tools

Job description

FITS is seeking a Quality Assurance professional in the Puerto Rico/United States region to oversee product complaints, investigations, and CAPA processes. The role requires 2–4 years in QA within regulated industries and solid knowledge of cGMP and FDA regulations, including data integrity (ALCOA+).

The candidate will monitor detractors, support investigations, identify trends, and assist with SOPs, GMP audits, and release activities, ensuring compliance across the organization.