QA Complaints Specialist

Flexible & Integrated Technical Services, LLC • Juncos, PR

1d

About The Position

For Quality Services. This role involves monitoring and tracking quality detractors, supporting complaint investigations, identifying trends, generating statistical summaries, developing solutions to database issues, writing SOPs, providing technical support, supporting product review and release, supporting GMP audits, and ensuring compliance with company policies and regulations.

Requirements

• 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+)
• Experience in Product complaint handling and investigations
• Experience in Root cause analysis and CAPA
• Experience in Complaint and/or service databases
• Experience in Trending and statistical analysis of quality data
• Experience in SOP writing and revision
• Experience in GMP audit support and product review/release activities

Nice To Haves

• Being self-motivated, curious, creative, and detail-oriented
• Commitment to serving customers with high-quality research and products
• Embracing a diverse work culture
• Environmental consciousness

Responsibilities

• 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

Benefits

• Flexible scheduling
• Family-oriented culture
• Focus on employee well-being

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level