JT796 - SPECIALIST QUALITY COMPLAINTS

Quality Consulting Group, LLC; Juncos (PR); Presencial; USD 90.000 - 110.000; Jornada completa

Descripción de la vacante

Quality Consulting Group, LLC is seeking a talented professional to join our team in Puerto Rico and the USA to manage product complaint investigations within a GMP-regulated environment. You will analyze data, update the database, and drive corrective actions to closure, while communicating outcomes to patients and partners.

The role requires a strong quality mindset, experience with CAPA and root-cause analysis, and proficiency with Microsoft Office and Teams to collaborate across the

Formación

• 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.

Responsabilidades

• Lead and manage product complaint investigations with data analysis and trending.
• Keep the complaints database updated and summarize closed investigations.
• Ensure investigations are concise and science-based by review/approval.
• Follow up on corrective actions through completion.
• Write clear closure letters to patients and partners and escalate as needed.
• Represent site on the product complaint network and communicate with stakeholders.

Conocimientos

Project management

Root cause analysis

CAPA

Quality mindset

Analytical

Problem-solving

Cross-functional collaboration

Educación

Bachelor's degree in related area

Herramientas

Microsoft Office

Microsoft Teams

Descripción del empleo

QUALITY CONSULTING GROUP,a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA

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.

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 Corrective and Preventive Action (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

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.