Specialist Quality Complaints (33088) - 1826797

🌟 Title: Specialist Quality Complaints - 33088

📍 Location: Puerto Rico Onshore/Virtual with administrative shift. 🏡🌐

Positions Requested: 1

SUMMARY

Primary responsibilities include supporting the product complaint system at Amgen by leading and managing product complaint investigations, performing data analysis, and trending complaint information to proactively detect signals and take appropriate actions in a timely manner.

Educational/Software Requirements:

• Doctorate degree or Master's degree and 3 years of directly related experience OR
• Bachelor's degree and 5 years of directly related experience OR
• Associate’s degree and 10 years of directly related experience OR
• High school diploma/GED and 12 years of directly related experience.

Engineering and Sciences backgrounds are preferred, but candidates with pharma industry experience will be considered. 🧪📊

Preferred Qualifications:

Experience in manufacturing/packaging deviations, Root Cause Analysis, complaint investigations, project management, and compliance. 💼🛠️

FUNCTIONS

• Keep the complaints database updated promptly with factual information and accurately summarize closed investigations. 📑🔍
• 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. 🔄🛠️
• Depending on the nature and complexity of the complaint, the specialist may conduct and document the investigation, requiring excellent writing skills to bridge technical details into a simple, concise document for non-technical reviewers. 📝🤝
• Additional responsibilities may include communication and escalation of complaints, site representation on the product complaint network, and generation/issuance of closure letters to patients and business partners. 📤👥

COMPETENCIES/SKILLS

• Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously. 🔄👥📊
• Excellent written and verbal communication skills, including facilitation and presentation skills. 🗣️📋
• Ability to work in a team-oriented, matrix environment and collaborate effectively with diverse departmental groups. 🤝🔄
• Self-motivated, able to interface effectively with various levels, attentive to details, able to prioritize and meet deadlines. 🚀🎯
• Excellent leadership, problem-solving, analytical, influencing, and customer service skills to operate and deliver results in a matrix-managed GMP environment. 💼🔍👩‍💼
• Computer literacy, ability to independently understand, follow, and implement instructions, work independently or as a team player, collaborate with outside resources. 💻🤝
• The ability to evaluate issues, make decisions, and determine when to escalate as necessary. 🧐🔄💡

To Apply:

Please send an updated resume to careers@proqualitynet.com along with the title "Specialist Quality Complaints - 33088." 📧📌