JT492 - SPECIALIST QUALITY COMPLAINTS

QUALITY CONSULTING GROUP, a leader in the 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 
• Complaints Owner 
• Experience in investigations and complaints.
• Full Bilingual both in writing and speak
• Experience leading cross-functional teams, and the ability to handle multiple projects simultaneously
• GMP environment.
• Trackwise 
• Administrative shift