QA Complaints Specialist

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

For Quality Services.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's degree in Science, Engineering, or a related field (or equivalent); 2–4 years of experience in Quality Assurance within a regulated industry (pharmaceutical, biotech, or medical device)
• Working knowledge of cGMP, FDA regulations, and data integrity principles (ALCOA+)
• Shift: 1st, 2nd, and 3rd shift according to business needs.
• Experience in:
  • Product complaint handling and investigations
  • Root cause analysis and CAPA
  • Complaint and/or service databases
  • Trending and statistical analysis of quality data
  • SOP writing and revision
  • GMP audit support and product review/release activities

The Personality Part:

• Being self-motivated means that you are curious and anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail, that nothing gets past you. If this sounds like you, and if you commit to serving customers with high-quality research and products, embracing a diverse work culture, and even the environment, you might just be what we’re looking for!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Monitor and track quality detractors using the service and complaint databases
• Support complaint investigations and help drive them to timely closure
• Identify significant trends and report them regularly 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

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?