Quality Complaints Investigator - CAPA & RCA

Quality Consulting Group, LLC; Juncos (PR); Hybrid; USD 80,000 - 120,000; Full time

Job summary

Quality Consulting Group, LLC seeks a highly motivated professional to support and lead product complaint investigations within a GMP environment in Puerto Rico and USA. The role emphasizes data analysis, science-based investigations, and timely corrective actions, with a strong writing ability to translate technical details for non-technical reviewers.

The candidate will excel in project management, cross-functional collaboration using Teams, and maintaining compliant quality documentation

Qualifications

• Bachelor's degree in related area.
• Five (5) years of directly related experience to the job.
• Experience in project management, root cause analysis, and CAPA determination and implementation.
• Strong quality mindset with comprehensive knowledge of quality systems, cGMP compliance, and regulatory requirements.
• Proficiency in Microsoft Office Suite, including Excel and Outlook.
• Experience using Microsoft Teams for communication, collaboration, and cross-functional meetings.
• Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities in a regulated environment.
• Administrative Shift

Responsibilities

• Supporting the product complaint system; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.
• Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.
• Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
• Follow-up on corrective actions derived from investigations through completion.
• Possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
• Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
• Problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment.

Skills

Project management

CAPA

Quality systems

cGMP compliance

Analytical skills

Problem solving

Microsoft Excel

Microsoft Teams

Organizational skills

Education

Bachelor's degree in related area

Tools

Microsoft Office Suite

Job description

Quality Consulting Group, LLC seeks a highly motivated professional to support and lead product complaint investigations within a GMP environment in Puerto Rico and USA. The role emphasizes data analysis, science-based investigations, and timely corrective actions, with a strong writing ability to translate technical details for non-technical reviewers.

The candidate will excel in project management, cross-functional collaboration using Teams, and maintaining compliant quality documentation