JT796 - SPECIALIST QUALITY COMPLAINTS

qualityconsultinggroup; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a skilled professional to lead product complaint investigations in a world-class manufacturing setting across Puerto Rico and the USA. The role requires strong data analysis, CAPA determination, and excellent documentation to communicate findings clearly to non-technical reviewers.

Candidates should have a Bachelor’s degree and at least five years of related experience, with a proven quality mindset and proficiency in Microsoft Office and Teams.

Qualifications

• Bachelor's degree in related area.
• Five years of directly related experience.
• Experience in project management, root cause analysis, and CAPA.
• Strong quality mindset with comprehensive knowledge of quality systems, cGMP, and regulatory requirements.
• Proficiency with Microsoft Office, including Excel and Outlook, and Teams.

Responsibilities

• Support the product complaint system; lead investigations and data analysis to detect signals.
• Keep the complaints database updated and summarize closed investigations.
• Ensure investigations are concise, clear, and science-based.
• Follow up on corrective actions through completion.
• Communicate complaints and issue closure letters to patients and business partners.
• Operate in a GMP, matrix-managed environment and demonstrate problem-solving and customer service skills.

Skills

CAPA

Root cause analysis

Project management

cGMP

Excel

Communication

Problem-solving

Education

Bachelor's degree in related area

Tools

Microsoft Office Suite

Microsoft Teams

Excel

Job description

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.